Senior Quality Assurance Specialist, Global Product Quality
Company: Cerevel Therapeutics
Location: Boston
Posted on: April 25, 2024
Job 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 Summary:
The 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
- 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 Required Qualifications
- 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% Desired
Qualifications
- Small molecule experience Education
- Bachelor's degree in life science field (or equivalent) or
engineering field relevant to pharmaceutical development
preferred
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.
Keywords: Cerevel Therapeutics, Revere , Senior Quality Assurance Specialist, Global Product Quality, Other , Boston, Massachusetts
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