Sr. Specialist, QA Operations
About The Position
The Sr. Specialist of QA Operations is responsible for providing Quality support for GMP manufacturing under general supervision. This role involves reviewing quality records related to GMP products manufactured by Contract Manufacturing Organizations (CMOs) for compliance to CGMPs, performing timely disposition of GMP products in accordance with applicable regulations and internal procedures, and participating in project teams as the QA representative. The Specialist will also independently provide Quality support for new product introduction (NPI) processes and interface with internal and external stakeholders to process quality records and resolve issues. Additionally, the role may involve leading or participating in deviation investigations, change control processes, audits of external suppliers, compliance inspections, and supporting other Quality functional areas to ensure compliance and promote continuous improvement.
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
- 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 (CMOs) 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
