What are the responsibilities and job description for the Quality Assurance Specialist II position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description:
- The Quality Assurance Professional will work in the Internal QA Operations Floor Support team of LTP Quality Assurance Department.
- This unit oversees internal manufacturing.
- Responsibilities:
- Support of Commercial QA Operations.
- Batch record issuance for use in manufacturing operations and review and approval of batch production records and associated supporting documentation (log books, forms, etc.).
- Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
Skills:
- Ability to complete all tasks under cGMP guidelines.
- Proficiency with Microsoft applications Outlook, Word, Excel, and PowerPoint;
- previous experience with TrackWise, LIMS, and SAP is preferred;
- ability to learn additional software applications as the need arises.
- Strong written and oral communication skills required.
- Prior QA experience is a requirement.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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