What are the responsibilities and job description for the Entry Level Validation Associate position at TRESUME?
Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies. - Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
Job Description:
- Approves Validation strategy and plans for the site.
- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.
- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.
- Review/approve investigation of operations in manufacturing/laboratory or other related operations.
- Oversee resolution of quality events, monitor that recurrent event are properly escalated and resolved.
- Ensure root cause is determined, evaluate impact on product quality, disposition, and corrective actions.
- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
- Contribute to the generation of the Annual Product Reviews.
Qualifications:
- Bachelor’s degree in Life Sciences or Master’s degree preferred.
- 0-2 year of experience in Pharmaceutical Manufacturing, combined of relevant experience in QA Validation role.
- In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 for computerized systems.
- Good organizational and time management skills.
- Quality oriented with attention to details.
- Proactive, self-motivated, professional, and dedicated.
Job Types: Full-time, Contract
Pay: $25.00 - $33.00 per hour
Benefits:
- Health insurance
- Life insurance
- Professional development assistance
- Referral program
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: One location
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