Senior QA Specialist - Contract - Cambridge, MA
Proclinical is seeking a dedicated and experienced Senior QA Specialist to join our dynamic team. This is a contract position located in Cambridge, MA.
Primary Responsibilities:
In this role, you will oversee the quality assurance process, ensuring that our products meet both local and global quality standards.
Skills & Requirements:
- Experience in a cGMP environment.
- Previous experience working with quality systems overseeing cGMP production operations including batch release, SAP, batch record review.
- Degree in a scientific discipline is preferred.
- Experience in regulatory inspection activities.
- Ability to manage multiple projects within tight timelines.
- Knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- SAP knowledge.
- Strong verbal and written communication skills.
- Ability to interact with peers, subordinate and senior personnel in multidisciplinary environment.
- Root cause analysis experience is preferred.
- Experience in vaccines is a plus.
The Senior QA Specialist will:
- Oversee all activities in accordance with quality and regulatory standards and procedures.
- Foster a quality-focused mindset and approach in all activities.
- Support continuous improvement culture and industrial excellence methodologies.
- Assist employees and respective departments with clear communication and action.
- Ensure proactive communication with customers for timely issue escalation and resolution.
- Support batch release of drug substance, including documentation compilation as needed.
- Review manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
- Provide on-the-floor support to Manufacturing.
- Perform SAP transactions related to batch record review.
- Maintain quality systems including Change Control, CAPAs, Deviations, Self-inspection auditing, QA reporting, and approval of GMP documentation.
- Support GMP compliance and inspection readiness within the organization.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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