Senior Quality Assurance Auditor

Posted 3 weeks ago

Position: Senior Quality Assurance Auditor

Department:   Quality Assurance

Senior Quality Assurance Auditor needed to manage the established CEL-SCI Corporation internal and external audit program.  Candidate to manage the CEL-SCI Audit program, perform internal audits of Current Good Manufacturing Practices (CGMP) processes and documentation supporting the manufacture and testing of a biopharmaceutical drug as well as perform external audits of suppliers and vendors of materials and services.  Overnight travel to these locations may be required.  Weekend and evening work may also be required.

Education and Experience:  

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

Skills/ Abilities:

  • Strong understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)
  • Strong understanding of current EU Regulations – Annex 13 and related
  • Ability to perform internal and external vendor/service provider audits as required (overnight travel required)
  • Master Control electronic Quality Management System software experience a plus
  • Batch record review, deviation investigations out of specification results, and CAPA investigations
  • Ability to gown for Clean Room activities
  • Gowning experience 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
  • Ability to lift/carry 30lbs.

Responsibilities:

  • Responsible for performing internal and external audits on suppliers/vendors as well as managing the established internal and external audit program for CEL-SCI Corporation.
  • Review and approve executed cGMP documentation and other documents relating to cGMP activities
  • Initiate new SOPs and/or revise existing SOPs as needed
  • Initiation, tracking and closure of Deviations, Change Controls, CAPAs and Out of Specification events
  • Review and approval of CGMP (equipment, inventory etc.) logbooks
  • Review, approval and release of raw materials for use in CGMP manufacturing and testing
  • Perform line/room clearances
  • When appropriate, assist in FDA inspections regarding regulated activities
  • Stay current with CFR and/or FDA guidance documents and EU regulations to ensure that compliance policies are up to date
  • Occasional weekend and evening work will be required, as well as overnight travel for audits
  • Assist in product label preparation
  • Present cGMP training programs to CEL-SCI employees
  • 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)
  • Other duties as assigned

Work Hours:  

Monday through Friday – 8am-4:30pm with 30-minute lunch or 8am-5pm with 1hr lunch (hours may vary on occasion and occasional weekend work may be required)

Location: 

Elkridge, MD (with travel to North Baltimore facility as needed) 

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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