Quality Assurance Specialist Job at Planet Group, Cambridge, MA

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  • Planet Group
  • Cambridge, MA

Job Description

Ideal Candidate Profile 

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

Job Tags

Contract work,

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