Sr. Specialist CQA

Neurocrine Biosciences • San Diego, CA

13d

About The Position

The Sr. Specialist of QA Operations is responsible for providing Quality support for GMP manufacturing under general supervision.

Requirements

• BS/BA degree in Life Sciences, Engineering, or related field and 4+ years of experience in quality within the pharmaceutical or biotechnology industry OR Master’s degree in Life Sciences, Engineering, or related field and 2+ years of similar experience as noted above
• Works well in a team environment
• Ability to work closely with both internal and external personnel
• Strong organizational and time management skills
• Ability to meet multiple deadlines with a high degree of accuracy and efficiency
• Attention to detail, critical thinker and effective organizational skills
• Strong verbal and written communication skills
• Ability to quickly assess new information and communicate requirements to the appropriate individuals
• Basic knowledge of FDA and EU regulations and ICH Guidelines and their applicability to CGMP drug substance and drug product manufacturing
• Hands-on experience reviewing quality records related to GMP manufacturing (e.g., batch records, labeling, deviation reports, specifications, change controls, CAPAs)
• Ability to identify and escalate problems and follow-through with corrective actions
• Experience with investigation methodologies (e.g., fishbone diagrams, 5 Whys, pareto charts)
• Experience with electronic quality management systems

Responsibilities

• Review quality records related to GMP products manufactured by Contract Manufacturing Organizations (CMO) for compliance to CGMPs
• Perform timely disposition of GMP products in accordance with applicable regulations and internal procedures
• Participate in project teams, serving as the QA representative and escalate issues to senior QA management when appropriate
• Independently provide Quality support for new product introduction (NPI) processes for new products and/or for substantial changes to existing products (e.g., new CMO, scale-up, process validation)
• Interface with internal and external stakeholders to process quality records and resolve issues
• Lead and/or participate in deviation investigation teams
• Participate in the change control process for changes related to clinical and/or commercial products
• May participate in or conduct audits of external suppliers
• May participate in compliance inspections and inspection readiness activities
• Support and interact with other Quality functional areas to ensure compliance with internal processes and procedures and to promote continuous improvement
• Other duties as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior