Job Description
Description:
Note:
***Remote*** any time zone Ideal 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.
Top 3 Must Have Skill Sets: - Some understanding and experience owning deviations and/or change control in GMP setting.
- Experience with Owning or QA approving GMP documents and records.
Nice to have: - 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.
Basic Qualifications: - 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
Preferred Qualifications: - 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.
Day to Day Responsibilities: - 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.
PAY RATE : $51/Hr on W2. "This posting is for Contingent Worker, not an FTE"
Job Tags
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