Department: Quality Assurance
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Quality Assurance Auditor performs CGMP audits of documentation supporting the manufacture and testing of a biopharmaceutical drug and audits of suppliers and vendors of materials and services. Reports to the Manager of Quality Assurance
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
- Strong understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)
- Familiarity with EU Regulations – Annex 1, 11 and 13 and other related
- Ability to perform internal and external vendor/service provider audits as required (overnight travel will be involved)
- Batch record review, out of specification results, and CAPA investigations
- 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
- Able to lift and carry 20 lbs.
- Review and approve executed cGMP documentation and other documents relating to cGMP activities
- Prepare, execute and follow-up of internal and external vendor/supplier, service audits
- 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
- Assist in product label preparation
- Present cGMP training programs
- 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
Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.
Overnight travel to suppliers and vendor will be required and limited local travel to other Company facilities may be required.
Elkridge, MD (with travel to North Baltimore facility also)
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume and cover letter to firstname.lastname@example.org. Reference the job title in the subject line of the email
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.