Quality Assurance Document Control (QA/DC) Specialist I

Posted 37 mins ago

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.

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