Sr. Specialist, QC

Neurocrine Biosciences

2d • $97,000 - $133,000

About The Position

Responsible for reviewing GMP analytical testing performed by contract sites and supporting internal GMP analytical laboratory operations.

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
• 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
• 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

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

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees