Quality Assurance Specialist job at Planet Group Cambridge, MA, US

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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