Celldex Therapeutics

Quality Assurance (QA) Specialist - Needham and Fall River, MA

US-MA-Needham | US-MA-Fall River

Overview

As a Quality Assurance Specialist III/IV at Celldex Therapeutics, you will use your life sciences industry experience to support various Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) operations. You’ll work at both our Needham and Fall River, MA sites plus occasionally travel overnight for business.

 

You’ll work with our team to review and audit complex documents and data (batch records, GMP and GLP protocols, GLP and GMP data); ensure compliance to Quality System procedures; and assure compliance to specs and standards by performing quality audits.

 

You’ll also provide Quality support for external and internal manufacturing, and clinical product distribution. This support includes employee training; revising SOPs and related manufacturing documents; assisting with investigations related to manufactured products; and performing internal/external audits and Contract Manufacturing Organization (CMO) site visits.

Responsibilities

  • Execute Quality Assurance systems to support lot release, GLP and GMP auditing and training. Observe manufacturing activities to support implementation of best practices and improvements.
  • Review manufacturing batch record, test record, and data forms. Review GLP protocols, reports, and clinical data transfers. Review/approve master and executed batch records. Review method and process reports for compliance. Write, review and approve SOPs.
  • Administer, review, follow-up and approve internal/external Deviations and Corrective and Preventive Action (CAPAs). Trend and report Quality systems related information (Deviations, CAPAs, etc.).
  • Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, and Clinical). Prepare routine updates and project status reports.

Qualifications

Required Skills:

  • Strong working knowledge of the Code of Federal Regulations (CFR), European Union (EU) regulations, and the International Council for Harmonisationof Technical Requirements for Pharmaceuticals for Human Use (ICH).
  • Strong written and interpersonal communication skills, and the ability to work independently and as part of a team.

 

Required Education/Experience:

  • Completed Bachelor’s degree in Chemistry, Biology, or related discipline.
  • Must have at least 6 years of Quality Assurance work experience in the biotech or pharmaceutical industries.

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