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Quality Assurance Specialist
675 W Kendall St Cambridge, MA 02142 US
Job Description
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
- 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.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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