QC Stability Manager
Company: Adverum Biotechnologies
Location: Redwood City
Posted on: October 22, 2024
Job Description:
Redwood City, CA Quality Control Full Time We are seeking a
highly motivated and experienced QC Stability Manager to join our
Quality Control team at Adverum. The QC Stability Manager will be
responsible for overseeing the stability program to ensure the
safety, efficacy, and quality of our products throughout their
shelf life. This role involves managing stability studies,
analyzing data, and ensuring compliance with regulatory
requirements. What you'll do:
- Stability Program Management:
- Develop, implement, and manage the stability program in
compliance with regulatory guidelines and company SOPs.
- Oversee the design and execution of stability studies,
including protocol development, sample management, and data
collection.
- Ensure timely initiation, monitoring, and completion of
stability studies.
- Identify opportunities for process improvements in the
stability program.
- Implement best practices and innovative solutions to enhance
the efficiency and effectiveness of stability studies.
- Stay current with industry trends, regulatory updates, and
scientific advancements related to stability testing. Data Analysis
and Reporting:
- Analyze stability data to assess product performance and
identify trends.
- Prepare comprehensive stability reports and summaries for
regulatory submissions and internal reviews.
- Ensure accurate and timely documentation and reporting of
stability data. Compliance and Quality Assurance:
- Ensure all stability studies comply with GMP, ICH guidelines,
and other relevant regulatory requirements.
- Conduct regular audits of stability studies and processes to
maintain high-quality standards.
- Implement corrective and preventive actions (CAPAs) as needed
to address any deviations or non-conformances. Collaboration and
Communication:
- Work closely with R&D, Quality Assurance, Manufacturing,
and Regulatory Affairs teams to ensure alignment and support for
stability studies.
- Serve as the primary point of contact for stability-related
inquiries and issues.
- Communicate stability study results and recommendations to
stakeholders and senior management.About you:
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical
Sciences, or a related field (Master's or Ph.D. preferred).
- Minimum of 8-10 years of experience in a Quality Control or
Stability role within the pharmaceutical or biotechnology
industry.
- Strong knowledge of GMP, ICH guidelines, and regulatory
requirements for stability testing.
- Experience with stability program management, including
protocol development, data analysis, and reporting.
- Excellent analytical, organizational, and problem-solving
skills.
- Strong attention to detail and the ability to manage multiple
tasks simultaneously.
- Effective communication and interpersonal skills to work
collaboratively with cross-functional teams.
- Proficiency in using laboratory information management systems
(LIMS) and other relevant software.
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Keywords: Adverum Biotechnologies, Lodi , QC Stability Manager, Executive , Redwood City, California
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