Quality Assurance Specialist (Life Sciences)

Category:

Life Science

Employment Type:

Contract

Reference:

BH-385164

Quality Assurance Specialist
Cambridge, MA (Hybrid, 2 days per week onsite)
Contract with perm potential
Pay Rate: $40 - $45 (depending on experience)

***The ideal candidate for this role will have 1 - 3 years' experience in a Quality Assurance support function with strong communication and interpersonal skills, assisting with QMS and quality events.

Must have experience with LCMS - Veeva (or something similar), technical writing exposure preferably procedural writing, revising documentation.

Other Experience:

• 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.

• 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).