Quality Assurance Document Control (QA/DC) Specialist I

Department : Quality Assurance

QA/DC position for filing and archiving of Good Manufacturing Practices (GMP) documents, updating/creating training records, document formatting/revision and other document processing

Education and Experience:  

• Bachelors Degree in life sciences, preferably biology or chemistry, or equivalent work experience
• 3+ years’ experience in Quality and/or Document Control in a pharmaceutical, biotechnology, or biopharmaceutical environment

Skills/Abilities:

• Advanced proficiency in Microsoft Office (Word, Excel, Outlook, Access, etc.)
• Proficient using Adobe Acrobat
• Experience with Microsoft Visio and/or Project preferred
• Experience with electronic Quality/Document Control systems preferred
• Extensive knowledge and experience in Good Documentation Practices
• Strong understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)
• Strong understanding of current EU Regulations – Annex 1, 11, 13 and other related
• Strong organizational skills and attention to detail
• Ability to work independently and in cross functional team in a collaborative manner
• Ability to work in a dynamic and fast paced environment
• Experience in GMP pharmaceutical, biotechnology, or biopharmaceutical industry preferred
• Able to gown into clean room garments and work within GMP clean room environments
• Knowledge of FDA and EU regulations preferred 
• Able to lift/carry 20 lbs.

Responsibilities:

• Produce/update documents by transcribing, formatting, inputting, editing, and copying text, data, and graphics
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Progressing documents through the electronic document management system 
• Review and edit documents as needed to ensure consistency, clarity, and adherence to regulatory requirements.
• Initiate new SOPs and/or revise existing SOPs as needed
• Ensure filing system is well organized and ensure records are retrievable 
• Process training records as they are submitted
• Fulfill document requests 
• Maintain databases by entering, reviewing, and updating data
• Protect organization's value by keeping intellectual property and documentation confidential
• Collaborate with cross-functional teams to facilitate document review, approval, and distribution processes
• Conduct risk-based investigations through using problem solving tools
• Participate in FDA and other regulatory agency inspections
• Track/report metrics/KPIs for quality activities to leadership teams as needed
• Provide training presentations as needed
• Performs other related duties as required and/or assigned

Work Hours:

Position is full time, on site.  Monday through Friday - 8:00–5:00 (with 1 hour lunch) or 8:30–5:00 (with 30-minute lunch).  Occasional early and late work and weekend work may be required.

Location: 

Elkridge, MD and North Baltimore, MD.  May require travel between CEL-SCI’s Baltimore and Elkridge Maryland locations.

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Facilities Engineer 

Department:  Facilities

The Facilities Engineer works under the direct supervision of the Director of Facilities.  The candidate will participate in the management of a safe and efficient constantly evolving work environment essential to the performance of GMP facilities.  The candidate should have the ability to adapt to changes in the work/facility environment and be self-motivated with a strong sense of ownership in areas of responsibility. Must be on call 24/7 to respond to facilities matters, security and Building/Equipment Monitoring Systems alarms (emergency response is assigned on a rotating basis).

Education:  

• Bachelor's Degree preferably in Engineering such as Mechanical, Electrical, or Biomedical with two (2) years of experience in engineering and maintenance in an FDA cGMP regulated manufacturing facility; OR

• Associate's Degree preferably in Engineering such as Mechanical, Electrical, or Biomedical with four (4) years of experience in engineering and maintenance in an FDA cGMP regulated research or manufacturing facility; OR

• High School Diploma with at least one year of education or training in a college, university or trade school plus six (6) years of relevant engineering work experience in a bio-pharma research, manufacturing facility operating under cGMP environment or related industry.

Experience: 

• Experience in facilities maintenance with at least 2+ years’ in an FDA cGMP regulated facility preferably in the pharmaceutical, biotechnology or biopharmaceutical industry.

Essential Functions:

• Perform a variety of maintenance/minor repair activities on the interior areas of the Facilities.

• Support Engineering projects and provide support to other departments as required. 

•    Responsible for authoring/revision of Facility Department SOPs. 

• Assure supervision of outside contract services ensure tasks are completed in accordance with contract/work orders, and all paperwork is complete.   

• Participate in and ensure all work orders are properly documented according to policies, procedures and Good Documentation Practices (GDP).

• Proactively seek ways to increase equipment reliability and operational efficiency.

• Participate in the oversite of contracted maintenance service by providers and contractors while they are on-site performing project work, maintenance, and/or repairs on facility’s structure, systems and equipment.

• Strong Project Management and communication Skills.

• Ensure safe working conditions are maintained in accordance with the Safety Program and directions from the Safety Officer and Facility management.

• Ensure the performance, condition and reliability of all plumbing, mechanical and electrical equipment including emergency equipment, and periodic testing of the same, to assure efficient, consistent and reliable operation.

• Report deviations arising from Building/Equipment Monitoring Systems to the Director of Facilities.

• Participate in an ongoing, periodic and annual assessment of facilities to identify any needed repairs and improvements. 

• Support installation, commissioning and validation activities for the Facility and Facilities Equipment.

• Be able to lift 50 lbs., climb a ladder and perform various minor maintenance, as needed.

• Participate on rotation basis on the Facility’s emergency call list (24/7), including weekends/holidays.

• Other tasks as assigned. 

The above statements are intended to describe the general nature of work performed by those in this position and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this position at any time which reflects management’s determination for assignment of essential functions.

Skills:

• Demonstrated ability to write facilities related SOPs and reports for an FDA cGMP regulated facility. 

• Knowledge of FDA, ICH, EU, UK regulations as they apply to facilities for the manufacture of injectable sterile medicinal products, a plus.

• Excellent organization and communication skills.

• Must have the ability to multi-task and coordinate workload by priority. 

• Strong analytical skills, particularly with respect to identifying and implementing technical solutions to process, utility and facility equipment / systems. 

• Proficiency in Microsoft Project, Word and Excel, and working knowledge of and experience with the following systems: Blue-Mountain, MS-Project, Siemens BAS are desired. Knowledge of CAD-system a plus. 

• Other computer skills and knowledge of various Facility and Facility equipment monitoring systems a plus. 

• Must comply with all applicable policies, rules and regulations of CEL-SCI and the Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and Company regulations such as the employee handbook and safety manual.

Work Hours:  

Position is full time, on site.  Monday through Friday – 7:30 a.m.-4:00 p.m. with 30-minute lunch or 8am-5pm with 1hr lunch (hours may vary on occasion).  After hours response to emergency required. Ability to work flexible schedule is required.

Location: 

Baltimore and Elkridge, Maryland - Full-Time (On-Site)  

Requires travel between CEL-SCI’s Baltimore and Elkridge Maryland facilities locations. 

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Quality Assurance Document Control (QADC) Manager

Department:  Quality Assurance

Quality Assurance Department is a support group to the Operational Departments of Manufacturing, Validation, Quality Control, R&D, Warehouse, and Facilities. The Quality Assurance Document Control Manager is responsible for performing technical functions in the QADC group, manages the daily operations of the QADC staff, and interacts with each group to ensure accurate and compliant documents are produced. This role ensures compliance of SOPs, policies, and procedures. This position reports to the Quality Assurance Director.

Education & Experience:

• Bachelor's degree in a relevant scientific discipline or equivalent work experience.
• In-depth knowledge of cGMP and regulatory requirements applicable to the pharmaceutical, biotechnology, or related industries.
• Experience working in FDA regulated environment a plus.
• 8+ years’ experience in a related GMP environment.

Skills & Abilities:

• Proficient knowledge of document control electronic systems (MasterControl preferred).
• Strong knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Access, and Adobe Acrobat.
• Strong technical writing and editing skills.
• Strong organization, presentation, and facilitation skills while paying attention to detail.
• Strong people management skills
• Excellent verbal and written communication skills.
• Ability to work independently and in cross functional team in a collaborative manner.
• Knowledge and experience with cGMP practices.
• Thorough knowledge and understanding of quality systems.
• Ability to lead project teams and work collaboratively to drive right first-time initiatives.
• Ability to work in a dynamic and fast paced environment.

Responsibilities:

• Develop and implement document control policies and procedures to ensure compliance with industry standards and regulatory requirements.
• Quality check all documents for conformance to plans, EDMS requirements.
• Verify the accuracy and completeness of cGMP documents.
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Maintain all GMP documents in a secure manner at all times.
• Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
• Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
• Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
• Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
• Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
• Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• Ensure adherence to cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the manufacturing process.
• Identify opportunities for process improvements and contribute to the development and implementation of enhancements.
• Organize timelines, schedules, and resources to ensure project milestones are met.
• Conduct risk-based investigations through using problem solving tools.
• Authors, reviews, and approved data/documents such as methods, procedures, policies, and/or protocols.
• Track/Report metrics/KPIs for quality activities to leadership teams as needed.
• Provide training/presentations as needed.
• Provide scheduled, structured training for all users of the EDMS, both internally and externally
• Support regulatory audits and inspections with respect to requested training and documentation needed.  Assist in audit preparation.
• Communicate and coordinate with other departments to ensure training and quality compliance.
• Be familiar with the day-to-day activities, personnel, and issues within the facilities.
• Stays current with latest industry trends, tools, and best practices, bringing forth new ideas and challenging status quo.
• Assist the Quality Assurance Management in daily operations, as needed.
• Manage subordinate staff in the day-to-day performance of their jobs.
• Performs other related duties as required and/or assigned.

WORK HOURS:

Position is full time.

Monday through Friday – 8:00-4:30 (with 30-minute lunch or 8:00-5:00 (with 1 hour lunch) 

LOCATION:

This is an onsite position at our Elkridge, MD site with some travel to the Seton facility (20 minutes North).

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Process Lead I

Department:  Manufacturing

The Process Lead participates in the manufacture of Leukocyte Interleukin, Injection (LI) under cGMP for clinical application, and facilities operations and maintenance.  The Process Lead reports directly to the Supervisor of Manufacturing.

Education & Experience:

• B.S. and 5+ years experience in related field

Skills & Abilities:

• Understanding and awareness of current Good Manufacturing Practices (cGMP) and basic familiarity with FDA and EU Guidelines
• Able to follow Standard Operating Procedures (SOP’s)
• Familiarity with MasterControl and associated requirements for creating and revising controlled documents
• Able to follow Master Batch Record when performing LI manufacture process steps
• Able to work in an ISO classified work environment
• Demonstrates good aseptic technique and ability to work in a biological safety cabinet
• Participate in required safety, GMP, and technical training sessions
• Coordinate training of newly hired or existing staff
• Training of newly hired staff
• Provide technical assistance to junior and new staff
• Contact vendors regarding new supplies or changes to existing supplies
• Troubleshoot minor problems that may occur during LI manufacture process in communication with management

Responsibilities include, but are not limited to:

• Participate in the manufacture of clinical LI
• Under direction from the Manufacturing Supervisor, Manager or Director, assist in the coordination and delegation of activities of junior staff in a specific process area
• Provide guidance to junior staff requiring process knowledge and experience
• Troubleshoot minor problems with the manufacturing process
• Proposes Changes to methods, design, or equipment
• Coordinate training of newly hired employees and current employees, if needed
• Requisition materials from warehouse needed for processing and for support work
• Clean, sanitize and monitor equipment, as assigned
• Troubleshoot problems with equipment
• Draft, revise and process various SOP’s and other related documents
• Able to follow and complete Batch Record
• Review completed Batch Records and forms prior to submission for compliance and accuracy
• Accurately and promptly complete timesheets / other required paperwork
• Attend and contribute to departmental and general staff meetings         

WORK HOURS:

Position is full time.

Monday through Friday with occasional Saturday work required. Normal business hours are 8:00 AM to 5:00 PM.  Occasional weekend and evening work will be required. 

LOCATION:

Elkridge, MD. 

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

IT Specialist - GMP Systems

Department:  Operations

The IT Specialist - GMP Systems is responsible for supporting a broad range of needs related to CEL-SCI’s GMP IT infrastructure and the use of electronic devices (i.e., desktop computers, laptop computers, network servers, tablets) that support the manufacturing and testing of our cancer immunotherapy, Multikine, as well as working with the Company’s IT consultant. Digital information assessed by, created by, and stored by CEL-SCI is highly confidential and must be protected from all outside parties.  As a biopharmaceutical company making a complex biological drug, the IT Specialist will ensure that CEL-SCI follows Current Good Manufacturing Practices (cGMP) as outlined in the US Code of Federal Regulations (CFR) Title 21 Parts 210 and 211, Part 11 and European Union (EU) Annex 11.0.  The IT Specialist reports to the Operations Department with its primary role to support the validation department during the GMP computer systems validation efforts.

Requirements:

Education & Experience:

• Bachelor’s degree or equivalent college level training, Computer Science degree preferred
• 5+ years’ experience in a pharmaceutical/biopharmaceutical environment
• Knowledge of FDA Title 21, Parts 210 and 211 cGMP (Current Good Manufacturing Practices), Part 11 (Electronic Records/Electronic Signatures) and EU Annex 11 (Computerized Systems)

Skills & Abilities:

• Strong understanding of Computer System GMP regulatory requirements (21 CFR Part 11, Annex 11)
• Strong technical writing and editing skills to draft IT Program Documents that support GMPs
• Capability to suggest and implement working solutions that meet cGMP computer system compliance
• Ability to administer multiple systems simultaneously
• Comfortability to work in a team environment to meet project deadlines
• Excellent communication skills
• Strong organizational skills
• Strong inventory tracking skills

Technical Competencies:

• Strong knowledge and abilities in Microsoft Office Applications
• Strong knowledge of Windows OS
• Strong Knowledge of Windows Server 2016 and newer
• Work experience setting up new Windows server from start to finish
• Strong knowledge of Active Directory, DHCP, DNS, Group Policy
• Strong knowledge of router/firewall configuration and maintenance
• Work experience with Cisco, Sonic Wall, and/or Ubiquiti router/firewall is a plus
• Strong knowledge of TCP/IP protocol
• Entry level knowledge of cloud solutions like Microsoft Azure
• Entry level knowledge of various computer programming languages 
• Knowledge of SQL Server and SQL programing is a plus

Responsibilities include, but are not limited to:

• Develop IT policies, Standard Operating Procedures (SOPs), and data storage requirements that fit within the overall GxP strategy and support quality standards to ensure compliance with regulatory guidelines
• Initiate, assess, implement, and approve change controls as they relate to IT and GMP computer systems
• Provide IT technical review for Standard Operating Procedures (SOPs), Computer Systems Validation (CSV) protocols, equipment specifications, etc., as appropriate
• Implement system securities and user access management restrictions to ensure data integrity
• Perform Data Integrity assessments and remediations for GMP computer systems periodically
• Develop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locations
• Collaborate within a team environment to ensure appropriate documentation of IT responsibilities throughout the CSV process
• Assist in the maintenance of a computer system inventory in accordance with the Computer System Validation Master Plan (VMP)
• Troubleshoot issues with computer systems during GMP manufacturing activities
• Train employees on IT procedures applicable to the GMP manufacture and testing
• Support the IT consultant in building  or repair network hardware and infrastructure
• Recommend IT purchases as needed
• Provide help desk services to employees
• Administer GMP computer systems to ensure alignment with GMP policies and procedures
• Assist the IT consultant with  local workstation permission settings, periodic review and back-up
• Other duties as assigned

Other:

• Ability to stand, walk, and sit for hours
• Ability to work in tight environments with little room for maneuvering
• Ability to lift up to 50 LBS

Work Hours:

Position is full time. Monday through Friday.  Occasional evening and weekend work may be required.  Travel to the R&D laboratory facility in Baltimore, MD (20 minutes north) will be required.  Must be able to work non-standard hours (weekends, evenings, nights) as needed.

Location:

Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Validation Technician

Department:  R&D and Validation

The Validation Technician is responsible for supporting validation activities of GMP equipment and systems.  Assists in specifying and selecting equipment. Maintains all records related to qualification and validation.  Prepares validation reports, suggests, and assists in determining specifications, and makes recommendations for modifications as necessary.  The Validation Technician reports to the Validation Engineer.

Education/Experience:

• B.S. in science or engineering or a related discipline
• 2-year degree and 1 to 2+ years of relevant experience
• No degree and 2 to 4 years of relevant experience

Skills/Abilities:

1. Demonstrates knowledge of Standard Operating Procedures (SOPs)

2. Demonstrates knowledge of Good Manufacturing Practice (GMP)
3. Develop technical expertise in reference to the Kaye validator
4. Participate in required safety, cGMP, and technical training sessions

Responsibilities include, but are not limited to:

1. Collects and analyzes validation data for temperature controlled units
2. Perform commissioning, qualification and validation activities
3. Recommends equipment operation specification changes
4. Collects data and prepares preliminary reports
5. Assist in equipment maintenance activities
6. Explore problems that occur and suggest appropriate solutions
7. Draft/revise GMP documentation including SOPs, Testing Standards, Specifications, Training Guidelines

WORK HOURS:

Position is full time.

This position requires local travel between CEL-SCI Facilities

LOCATION:

Baltimore & Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

• Bachelor’s degree in Human Resources, Business Administration, or related field required.
• A minimum of 7-10 years of human resource management experience preferred.
• SHRM-CP or SHRM-SCP highly desired.

• Working understanding of human resource principles, practices and procedures
• Excellent verbal and written communication skills 
• Excellent interpersonal and customer service skills
• Excellent time management skills with a proven ability to meet deadlines 
• Excellent organizational skills and attention to detail
• Strong analytical and problem-solving skills
• Ability to act with integrity, professionalism, and confidentiality
• Experience in hiring and managing shifts
• Proficient with Microsoft Office Suite and Human Resources Information System (HRIS) software (i.e., ADP)

• Manages the talent acquisition process, which includes recruitment, interviewing, and hiring of qualified job applicants; collaborates with departmental managers to understand skills and competencies required for openings, work with outside recruiters
• Ensure new hire paperwork is completed and processed
• Assist in employee orientation, development, and recordkeeping
• Assist with compensation and benefits administration and recordkeeping
• Preparing and/or updating employment records related to hiring, transferring, promoting, and terminating
• Assist in ensuring that HR policies, procedures and corporate culture are related clearly to new and existing employees
• Assists in the administration of company benefit plans, including enrollments, changes and terminations
• Assists with the preparation of the performance review process
• Analyzes trends in compensation and benefits; researches and proposes competitive base and incentive pay programs to ensure the organization attracts and retains top talent.
• Creates learning and development programs and initiatives that provide internal development opportunities for employees 
• Assist with employee disciplinary meetings, terminations, and investigations.
• Maintains compliance with federal, state, and local employment laws and regulations, and recommended best practices; reviews policies and practices to maintain compliance.
• Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
• Performs other duties as assigned.