Quality Systems Specialist
Posted on :
18-06-2024
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Job Role: Quality Systems Specialist
Location: Lake Forest IL
Contract: W2
Job Description:
- Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products medical devices combination products and biologics. Specific areas of support may include the Document Center Device QA Labeling Validation Training and CAPA.
- Assist with proper integration and support of quality regulations: drug biologics device and/or combination products.
- Assist project teams in planning preparation review and approval of quality documentation.
- Complete and route change requests for process document creation maintenance and implementation.
- Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
Qualifications:
- Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/ scientific area preferred.
- 3 years experience in quality assurance quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality Regulatory Process Sciences Manufacturing Operations.
- Knowledge and familiarity with product process equipment and facilities of pharmaceutical biological or device related products preferred.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Strong oral and written communication skills needed.
Employment Type
Full Time
Key Skills
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