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,