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QMS & Doc Control Specialist - Contractor
169921
Posted:
02/07/2025
- 60 USD - 60 USD
- Watertown, United States
- Contract
Quality Assurance Administrator
Job Title: QA Administrator
Location: Watertown, MA (On-site)
Hours: 15-20/week on W2 – 6 months
Department: Quality Assurance
Position Introduction:
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. he QA Administrator will play a critical role in maintaining documentation, supporting quality systems, and supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline.
Role and Responsibilities:
Qualifications:
Job Title: QA Administrator
Location: Watertown, MA (On-site)
Hours: 15-20/week on W2 – 6 months
Department: Quality Assurance
Position Introduction:
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. he QA Administrator will play a critical role in maintaining documentation, supporting quality systems, and supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline.
Role and Responsibilities:
- Manage the lifecycle of controlled documents (SOPs, forms, policies, batch records, etc.) within the electronic Document Management System (eDMS).
- Ensure documents are reviewed, approved, and distributed in a timely and compliant manner.
- Manage and review revisions to controlled documents and ensure document changes are adequately documented and justified.
- Manage the issuance of controlled GMP documentation including production batch records, logbooks, labels and forms ensuring compliance with document control procedures.
- Support supplier qualification program including material release.
- Support document-based training activities within the EDMS system, including assignment and tracking of GMP and QA-related training materials
- Ensure documentation is maintained accurately and timely in compliance with GDP (Good Documentation Practices). Support document archival process.
- Support audits and inspections by regulatory agencies, clients, and internal stakeholders.
- Provide administrative support to QA leadership and cross-functional teams.
- Participate in continuous improvement initiatives related to quality systems.
Qualifications:
- 3+ years of experience in a GMP-regulated environment, preferably in biotech, pharma, or cell/gene therapy.
- Previous experience with electronic Document Management Systems essential.
- Excellent attention to detail and organizational skills.
- Strong verbal and written communication skills.
- Ability to work in a fast-paced, dynamic environment and collaborate effectively across teams.
Martin Wenzel
Senior Division Director