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Specialist Product Quality
Advanced Bio-Logic Solutions Corp Thousand Oaks , CA 91320
Posted 2 weeks ago
Description:Note:
Remote any time zoneIdeal candidate:
Remote any time zoneIdeal candidate:
- B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, or manufacturing environment- at least 10 years exp.
- Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
- Previous experience using VEEVA, Track wise and quality systems.
- Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing.
- Some understanding and experience owning deviations and/or change control in GMP setting.
- Experience with Owning or QA approving GMP documents and records.
- Experience with Product Quality monitoring - APR (Annual Product Review), product monitoring, process monitoring, specifications/In Process controls, or IND/CTA/MA filings.
- Doesn't have filing knowledge not a deal breaker.
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Familiar with pharmaceutical sciences, quality, compliance and regulatory GMP requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
- B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
- Previous experience using VEEVA, Track wise and other quality systems.
- Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
- Strong project management skills.
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
- Previous experience working on a cross-functional team in a matrix environment.
- Excellent written and verbal communication skills, including facilitation and presentation skills.
- Own deviation or change control records for the Product Quality department, leading cross-functional investigation or change planning teams.
- QA review and approve product specifications, deviation, and change control records.
- Use of business tools such as Teams and Smartsheet's, as well as GMP systems such as VEEVA and Track Wise.
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