We are currently supporting a requisition for a QA Specialist I at a leading Biopharmaceutical client in San Dima, CA.
Job role will be required to be on-site to obtain information necessary to complete the investigation with periodic gowning to be performed to enter into classed areas. Job role is considered to be flexible-location dependent."
Description
- Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
- Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
- Must have strong writing skills to present findings in a clear and concise manner.
- Must be detail-oriented and able to demonstrate a high standard of integrity.
- Must have a desire to demonstrate excellence by setting high standards.
- BS/BA degree and a minimum of 2-3 years of relevant experience. QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).
Knowledge
- Must have an understanding and application of QA principles, concepts, industry practices, and standards.
- Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
- With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action.
- Normally receives no instruction on routine work, general instructions on new assignments.
- Strong verbal, technical writing, time management and interpersonal skills are required
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