Quality Assurance Auditor II | CEL-SCI

Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control, Warehouse, and Facilities. The Quality Assurance Auditor II is responsible for performing technical functions in the Quality Assurance group and interacts with each group to ensure accurate and compliant release of intermediates and final product. This role ensures compliance with SOPs, policies, and procedures. Weekend and evening work will be required.Education and Experience:Bachelor’s degree in life sciences, preferably biology or chemistry, or equivalent work experience2+ years’ experience in a CGMP Quality Assurance role in the pharmaceutical, biotechnology, or biopharmaceutical industrySkills/Abilities:Understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)Understanding of current EU Regulations – Annex 1, 11, 13 and other relatedAbility to perform internal audits as requiredManufacturing Batch record reviewQuality Record investigation and approvalCapable of gowning into and performing QA functions in ISO 5, 6, 7, & 8 classified cleanroomsStrong 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 soundKnowledge of electronic documentation Quality Management Systems a plus (MasterControl preferred)Ability to work in a dynamic and fast-paced environmentAbility to lift/carry 30lbsResponsibilities:Review and approve executed cGMP documentation and other documents relating to cGMP activitiesPrepare, execute, and follow-up of internal and external vendor/supplier auditsInitiate new SOPs and/or revise existing SOPs as neededInitiation, tracking, and closure of quality records like Deviations, Change Controls, CAPAs, and Out of Specification (OOS) recordsAssist with investigation and closure of product complaints, supplier complaints, and adverse eventsReview and approval of CGMP logbooks (equipment, inventory, etc.)Review, approval, and release of raw materials for use in manufacturing and testingConduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standardsPerform QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real-time, cleaning documentation, logbooks, and resolving issues that occur during manufacturingProcess Supplier Change NotificationsCommunicate and coordinate with other departments to ensure training and quality system complianceWhen required, assist in FDA and other regulatory agency inspectionsStay current with CFR and/or FDA guidance documents and EU regulations to ensure that compliance policies are up to dateAssist with tracking/reporting metrics/KPIs for quality activities to leadership teams as neededProvide training presentations as neededParticipate as QA floor representative during manufacturing operationsTravel between two CEL-SCI CGMP facilities (North Baltimore and Elkridge MD) to perform the above functions will be requiredOccasional weekend and evening work will be requiredPerform other related duties as required and/or assignedWork 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 (20 minutes).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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