Senior Quality Assurance Specialist

Senior Quality Assurance Specialist -Contract - Cambridge, MA

Proclinical is seeking a dedicated and experienced Quality Assurance Specialist to join a dynamic team for a Senior position.

Primary Responsibilities:

In this role, the successful candidate will play a crucial part in overseeing the quality assurance process, ensuring that all products consistently meet both local and global quality standards.

Skills & Requirements:

• Bachelor's degree in a scientific discipline.
• Experience in a cGMP environment.
• Previous experience with quality systems overseeing cGMP production operations, including batch release, SAP and batch record review.
• Experience in regulatory inspection activities is desirable.
• 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 is beneficial.
• Strong verbal and written communication skills.
• Ability to interact effectively with peers, subordinates, and senior personnel in a multidisciplinary environment.
• Root cause analysis experience is preferred.
• Experience with vaccines is an advantage.

The Senior Quality Assurance Specialist's responsibilities will be:

• Execute all activities in accordance with quality and regulatory standards and procedures.
• Foster a culture of quality excellence in all activities.
• Support continuous improvement and industrial excellence methodologies.
• Provide clear and proactive communication to customers to ensure timely resolution of issues.
• Support the batch release of drug substance, including documentation compilation as needed.
• Review manufacturing batch records for completeness and compliance with cGMPs.
• Provide on-the-floor support to Manufacturing.
• Perform SAP transactions related to batch record review.
• Maintain quality systems including Change Control, CAPAs, Deviations, and Self-inspection auditing.
• Support GMP compliance and inspection readiness within the organization.
• Assist in coordinating work for the QA Operations team to facilitate timely product lot release.
• Review calibration and work order activities.

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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