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Quality Assurance Auditor

Employer
CEL-SCI Corporation
Location
Elkridge, MD
Start date
Jul 19, 2022

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Discipline
Administration, Accounting, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

Department: Quality Assurance

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

Skills/ Abilities:

  • 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.

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, 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

Work Hours:

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.


Location:

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 . 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.

 

 

Company

CEL-SCI Corporation is a pioneer in cancer immunotherapy. We are a clinical-stage biotechnology company focused on finding the best way to activate the immune system to fight cancer, infectious and autoimmune diseases. CEL-SCI believes that boosting a patient's immune system before surgery, radiation and chemotherapy should provide the greatest possible impact on survival since that is the time when the immune system is the strongest. Therefore, in the Phase 3 clinical study CEL-SCI treated patients who were newly diagnosed with head and neck cancer with Multikine immunotherapy right after diagnosis, BEFORE they went on to receive surgery, radiation and/or chemotherapy. This approach is unique since cancer drugs are mostly given after surgery, radiation and chemotherapy have failed. The Phase 3 study is the largest ever in head and neck cancer with 928 patients enrolled. It reached the targeted threshold required to conduct data evaluation and is currently in the statistical analysis phase. Head and neck cancer represents about 6% of all cancers worldwide and an unmet medical need. Multikine has received Orphan Drug designation from the FDA for this indication. CEL-SCI operates its own 73,000 sq. ft. GMP manufacturing facility that produces Multikine and a separate research & development laboratory that supports the manufacturing of Multikine. CEL-SCI has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Stock Symbol: CVM

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Find Us
Website
Phone
(703) 506-9460
Location
8229 Boone Boulevard
Suite 802
Vienna
VA
22182
United States
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