What are the responsibilities and job description for the Quality Assurance Specialist II/III position at Celldex Therapeutics?
Overview
Celldex is a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Celldex has validated pipeline programs, an experienced management team who pioneered early antibody technologies, and support from leading healthcare investors. At Celldex, you’ll work with some of the industry’s most talented scientists and business professionals in a meaningful, inclusive, and exciting work environment.The QA Specialist II/III supports Quality Assurance functions focused on manufacturing operations. The position will review/audit documents including solution records, batch records, QC test and stability data, validation documentation; ensure compliance to defined Quality System procedures focusing on EM alert/actions and deviations. In addition, the individual will release raw materials, assign equipment ID numbers, assist with audits including following up on corrective actions, revise standard operating procedures and related manufacturing documents, and assist with investigations related to manufactured products.
Responsibilities
- Reviews documentation for compliance including executed batch records and solution records
- Follows defined quality procedures
- Inputs quality metrics into applicable databases
- Assist in the execution of QA systems to support lot release, audit and training
- Assists in performing disposition of raw materials or products utilizing defined procedures and specifications
- Assist with Equipment Registration process and review, Calibration reports, OOTs (Out of Tolerance)
- Write, review and approve SOPs, production records
- Assists with QA oversight of Work Order Program
- May assist with quality oversight of validation initiatives
- Review QC test data including stability testing
- Trend and report QA related information (Deviations, CAPA, Actions, Nonconformances, etc.)
- May contribute to the preparation of routine updates and project status reports of Quality Assurance activities
- May participate in auditing (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, Due Diligence)
- May assist departments with investigations related to manufactured products or environmental excursions
- Reconciles, scans and files documentation as needed
Qualifications
- Bachelor Science degree in Chemistry/Biology or related discipline
- 3 years QA or manufacturing experience in Biotech/Pharma industry for Level II or 5 years for Level III
- Manufacturing Cell culture and purification experience preferred
- Strong knowledge of MS Word, and Excel
- Strong written and interpersonal communication skills
- Ability to work in a cleanroom environment
- Working knowledge of CFR and ICH guidelines.
- The ability to work independently and as part of a team
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
