Quality Assurance Auditor

Elkridge, MD
May 21, 2022
Required Education
Bachelors Degree
Position Type
Full time
Department: Quality Assurance

To address this issue, the drug enforcement administration (dea) has adopted a "pre-approval" process that combines data-driven assessment with risk-based review to identify and mitigate issues that could present abuse liability. It is the only fda approved drug that treats a bacterial infection caused by streptococcus bacteria, which is the main cause of a bacterial infection of Singosari order hydroxyzine online the throat called acute pharyngitis. The azithromycin online pharmacy has partnered with the top pharmacies online.

Kamagra deutschland is a drug that’s used to treat a lack of sex drive. All but three of clomid online kaufen the participants (2 m, 1 f) were fully compliant with the treatment, and there was no dropout of participants during the study. They are bacteriocidal, anti-inflammatory, nonstimulating, and are safe to use for any length of time when applied to the skin.

Amoxil, amoxil cost, amoxil generic name, and amoxil, amoxil, generic, and brand name of a broad-spectrum antibiotic used for oral administration. I’ve already mentioned, in both my previous posts, and in this new order cytotec pills externally one, that my own experience with pms is a bad. Neurontin withdrawal seizures (nwess) as well as antiepileptic drug-refractory status epilepticus (ase) seizures are common phenomena in patients with epilepsy.

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.


  • 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.


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


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.