Senior QA Specialist

US$55 - US$62 per hour + Highly Competitive Salary
  1. Contract
  2. Senior/Director & VP, Good Manufacturing Practice (GMP)
  3. United States
Cambridge, USA
Posting date: 22 May 2024

This vacancy has now expired. Please see similar roles below...

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.


  • $55 - $62 per hour

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or

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.