Quality Assurance Specialist

Quality Assurance Specialist - Contract - Cambridge, MA

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

Proclinical is seeking a Quality Assurance Specialist to join our client's team in Cambridge, MA.

Primary Responsibilities:

The successful candidate will focus on document management and quality operations within the cardiovascular pharmaceuticals sector. Your expertise will support continuous improvement initiatives and ensure compliance with industry standards.

Skills & Requirements:

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) or equivalent combination of education and experience.
• Minimum 1-3 years of experience in a quality assurance/quality operations role within a regulated manufacturing environment, preferably in finished goods.
• Working knowledge of GMP, ISO standards, and regulatory requirements for finished goods manufacturing
• Excellent attention to detail and strong analytical skills.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and familiarity with quality management systems (QMS).
• Ability to work independently, manage multiple priorities, and meet deadlines.
• Prior experience in pharmaceutical, medical device, food, or consumer goods industries.

The Quality Assurance Specialist's responsibilities will be:

• Document Management
• Redline and initiate Finished Goods Specification creation and revisions
• Upload any new External Manufacturing documents in doc control system, e.g., Master Production Records, Specifications, BOMs
• Route SOPs for review/approval
• Initiate External Deviations & Change Control
• Create records within eQMS to document external deviations and change controls
• Support continuous improvement initiatives related to quality operations, including process optimization and system improvements.
• Create and draft Work Instructions and Job Aids supporting the Finished Goods QA team
• Collaborate with cross-functional teams (Manufacturing, Supply Chain, Regulatory) to resolve quality concerns.
• Ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., FDA, ISO).

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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