Quality Assurance Specialist

Pay $40-$45/hr on w2 
Location: hybrid – 2 days per week ; Cambridge, MA
Responsibilities:

• 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).

Relevant 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.

• Experience with/ LCMS – Veeva, but a similar tool is ok  
• Technical writing exp – procedural writing 
• Organized communication, strong interpersonal skills, the QA function is a support function, so understand the problem, communicate, and collaborate 
• Min. Years of experience required: Minimum 1-3 years of experience; not looking for someone too senior