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Sr. Specialist – Qc
| Company | Neurocrine Biosciences |
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| Location | San Diego, CA, USA |
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| Salary | $95100 – $138050 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- B.S. Degree in Chemistry, Biology, or related field and 4+ years of experience within the pharmaceutical or biotechnology industry OR
- Master’s and 2+ years of related experience
- Experience applying CGMP requirements in a Quality Control setting
- Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation
- Experience in analytical development and/or testing in a Quality Control setting
- Experience with using electronic documents management systems, laboratory data management systems, document control and records management
- Knowledge of US FDA and European regulations and ICH Guidelines
- Works well in a team environment
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Capable of handling multiple responsibilities and prioritizing appropriately
- Attention to detail, critical thinker and effective organizational skills
- Ability to identify and escalate problems and follow-through with corrective actions
- Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
- Apply problem-solving tools for root cause analysis
- Excellent computer skills
- Strong communication skills
Responsibilities
- Review and approve API and drug product analytical records for clinical and commercial products
- Review and approve stability data supporting retest period assignment for clinical and commercial products. May perform analytical testing to support stability studies, as needed
- Review and approve analytical test method validation protocols and reports. May perform analytical testing to support validation activities, as needed
- Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab
- Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
- Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues
- Participate in deviation and laboratory investigation teams
- Review and compile data for regulatory submissions
- Conduct and support audits of external vendors
- Assist during onsite inspections and inspection readiness activities
- Perform additional duties as assigned by management
Preferred Qualifications
- Experience with quality systems in analytical testing for the biologics industry strongly desired.
