Technical Manager, EQA (S. San Francisco, CA)
We are proud to offer an exciting temp. opportunity to work as a Technical Manager at an innovative, entrepreneurial and well-known Pharmaceutical company located in the South San Francisco. Join this team of employees who are helping to improve healthcare by developing and manufacturing pharmaceutical products that positively affect the lives of patients.
Temporary Assignment for 6 months (will most likely extend longer)
- Ensure the manufacture and disposition of clinical supplies of Our Company's Small Molecule GMP intermediates, APIs and Drug Products including primary packaging at CMOs is conducted in accordance with cGMP.
- Create and maintain Quality Agreements & Product Specifications from a template.
- Review and approve CMO master batch records for compliance to regulatory filings, product requirements, and cGMP compliance.
- Review executed batch records, assess deviations/investigations.
- Review and approve CMO analytical method transfers and method qualifications protocols/reports with Our Company's QC.
- Implement process improvements.
- Represent External Quality to support Quality Subteams.
- At least 8 years clinical development experience with Small Molecules Development in particular in API and solid dosage form manufacturing
- At least 4 years direct experience in Quality for pharmaceutical operations
- At least 3 years experience in operating quality systems in pharmaceutical operations
- Demonstrated proficiency in interpretations of cGMP regulations, both US and international
- BS/MS in life sciences or equivalent
Kelly Temporary Employee Perks
- Kelly-sponsored Affordable Care Act health care coverage available for eligible employees
- Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable*
- Service bonus plan
- Holiday pay plan
- Weekly electronic pay options
- Free online training campus available
- Exclusive online employee community
- Employee assistance program (EAP) available at no cost
- Corporate discounts
- Transportation spending accounts
*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.
Apply today for immediate consideration.
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