- Ensure GMP compliance for outsourced manufacturing, packaging, labeling, testing & distribution activities
- Review GMP documentation such as Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors
- Review executed batch records and analytical data, to ensure timely disposition of drug substances, drug products and finished goods for use in clinical trials and commercial operations
- Review product quality investigations, including but not limited to, quality events, deviations, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing
- Ensure investigations are robust and properly documented (including root cause analysis, product quality impact assessment, CAPA)
- Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects' timelines. Escalate issues to Manager in timely manner
- Work collaboratively with Global Quality staff and other functional area partners to ensure GMP compliance with Cerevel and regulatory requirements
- Support enhancements to electronic quality management system and other continuous improvement activities
- Author/update Standard Operating Procedures, Work Practices, and other related documents
- Additional responsibilities may be assigned based on business needs of a growing organization
- 4-5 years of related experience in pharmaceutical industry in Quality Assurance or Quality Control role supporting GMP Activities for clinical trials and/or commercial products
- Understanding of GMP requirements and the drug development process
- Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs
- Ability to handle interactions and resolve issues with internal customers and vendors in a tactful, professional, and effective manner
- Highly motivated, flexible, and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and attention to detail
- Strong verbal and written communication skills
- Experience in authoring and implementing SOPs
- Experience working in electronic quality management systems (Veeva or equivalent)
- Ability to travel as needed, may be up to 20%
- Small molecule experience
- Bachelor's degree in life science field (or equivalent) or engineering field relevant to pharmaceutical development preferred
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Senior Quality Assurance Specialist, Global Product Quality - Boston, United States - Cerevel Therapeutics
Description
Company Overview
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role SummaryThe Senior QA Specialist, Global Product Quality implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP vendors that are utilized in the manufacturing, packaging, testing and distribution of Cerevel products.
Key Responsibilities
Required Qualifications
Desired Qualifications
Education
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
