Quality Assurance Auditor II

Position: Quality Assurance Auditor II

Department : Quality Assurance

Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control, Warehouse, and Facilities. The Quality Assurance Auditor II is responsible for performing technical functions in the Quality Assurance group and interacts with each group to ensure accurate and compliant release of intermediates and final product. This role ensures compliance of SOPs, policies, and procedures. Weekend and evening work will be required. 

Education and Experience:  

• Bachelor’s degree in life sciences, preferably biology or chemistry, or equivalent work experience
• 2+ years’ experience in a CGMP Quality Assurance role in the pharmaceutical, biotechnology or biopharmaceutical industry

Skills/ Abilities:

• Understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)
• Understanding of current EU Regulations – Annex 1, 11, 13 and other related
• Ability to perform internal audits as required
• Manufacturing Batch record review
• Quality Record investigation and approval
• Capable of gowning into and performing QA functions in ISO 5, 6 , 7, & 8 classified cleanrooms
• Strong computer skills, including use of all components of Microsoft Office (Word, Excel, Outlook, Access, etc.)
• Ability to prepare technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
• Knowledge of electronic documentation Quality Management Systems a plus (MasterControl preferred)
• Ability to work in a dynamic and fast paced environment
• Ability to lift/carry 30lbs

Responsibilities:

• Review and approve executed cGMP documentation and other documents relating to cGMP activities
• Prepare, execute and follow-up of internal and external vendor/supplier audits
• Initiate new SOPs and/or revise existing SOPs as needed
• Initiation, tracking and closure of quality records like Deviations, Change Controls, CAPAs and Out of Specification (OOS) records
• Assist with investigation and closure of product complaints, supplier complaints, and adverse events
• Review and approval of CGMP logbooks (equipment, inventory etc.)
• Review, approval and release of raw materials for use in manufacturing and testing
• Conduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standards
• Performs QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing
• Process Supplier Change Notifications
• Communicate and coordinate with other departments to ensure training and quality system compliance
• When required, assist in FDA and other regulatory agency inspections
• Stay current with CFR and/or FDA guidance documents and EU regulations to ensure that compliance policies are up to date
• Assist in product label preparation
• Assist with tracking/reporting metrics/KPIs for quality activities to leadership teams as needed
• Provide training presentations as needed
• Participate as QA floor representative during manufacturing operations 
• Travel between two CEL-SCI CGMP facilities (North Baltimore and Elkridge MD to perform the above functions will be required)
• Occasional weekend and evening work will be required
• 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 (20 minutes).

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.