Rockville Categories:
QA Specialist (014-13-01) MacroGenics
THIS JOB HAS EXPIRED
Location: Rockville, MDApplicants must meet the following requirements:
Bachelor?s degree with a minimum of eight years experience, or Master?s degree with a minimum of five to eight years experience; Quality Auditor Certification a plus
Experience working directly with CMOs and hands-on experience reviewing drug substance batch records, performing CMO audits, and clearly articulating observations from batch records and on-site audits in written reports
Knowledge and proficiency with personal computers and applicable software packages (Microsoft Word, Excel)
Experience with TrackWise, LIMS, and use of Risk Management tools a plus
Must be able to handle multiple priorities at once and work on complex problems exercising independent judgment in developing solutions
Must be able to work independently with minimal supervision
The selected candidate will be responsible for:
Acting as primary QA contact for quality issues and correspondences supporting lot release
Reviewing and approving master and executed batch records for drug substance lots manufactured at CMO
Performing on-site audits of CMO for cGMP compliance
Reviewing QC test data for the lot and approval of COA for lot release
Ensuring that all quality-related issues surrounding the lot/batch are resolved
Managing timelines effectively to ensure a timely release of the lot/batch to meet clinical supply needs
Attending internal meetings as necessary and providing lot release status updates
Assisting with special QA projects and other duties as assigned
Benefits: Competitive salary and benefits package
Qualified applicants, please use the following link to apply:
https://trak.baiworks.com/application/login.aspx?q=6QrQ6doh%2bItpPeYeK3mBGWWCE5ELPDpmpYF5rdM99oE%3d
Visit www.macrogenics.com for more details.
| Location: | 1500 East Gude Drive Rockville, MD 20850 United States |
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THIS JOB HAS EXPIRED
MacroGenics
Investors: Alta Partners, Hunt Ventures/Hunt BioVentures, InterWest Partners, MPM Capital, RiverVest Venture PartnersAll Jobs: at MacroGenics
| Web Site: | www.macrogenics.com |
|---|---|
| Headquarters: | 1500 East Gude Drive Rockville, MD 20850 United States |
| Industry: | Biotechnology |
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