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Senior Manager, Quality Control Product Release and Stability

Company: Loves Furniture
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Position: Senior Manager, QC Product Release and Stability Location: Cambridge, MA
Job Id: 210201 # of Openings: 1 Summary: Solid's Start: Solid is the English translation of Eytan, the Hebrew name of Solid's co-founders Ilan and Annie Ganot's son, Eytani, who was diagnosed with Duchenne muscular dystrophy (Duchenne) in 2012 at the age of 3. Unsatisfied with the existing Duchenne treatment landscape, the Ganots built a disease-focused company with the people and potential to advance innovative science quickly and responsibly. Solid's Culture:--Much of what you can learn about Solid and our culture can be found in our name. We come to work each day for the Duchenne community, and that community is our family. We have a collective strength and determination that propels us to embrace innovation and challenge the status quo because central to all that we do is the unwavering commitment to advance meaningful therapies for the Duchenne community. We are a fiercely passionate and committed team, driven to collaborate with thoughtfulness and respect. We value exceptional skills, scientific curiosity, entrepreneurial spirit, diversity and adaptability. #TogetherWeAreSolid in our mission to find a cure for Duchenne muscular dystrophy and we will not stop until we've done it. Solid Biosciences is looking for a Senior Manager, Quality Control Product Release and Stability who will be responsible for managing and executing QC activities in support of product production, release, and stability. This individual will also ensure GMP activities are conducted in accordance with applicable SOPs, compendia, approved methods, and in accordance with company's and regulatory agencies' policies and procedures. Key Duties & Accountabilities:

  • Management and presentation of QC data at Operations Team meetings with high level of accuracy
  • Coordinates testing with external contract testing laboratories. Ensures the timely execution of release tests by external laboratories to facilitate batch disposition under accelerated timelines
  • Maintain repository of all QC data easily accessible to key stakeholders
  • Perform data review and trending for in-process testing, release, and stability. Use statistical methods to evaluate method performance. Identify data trends, ensure compliance with regulatory filings and ICH or other global health authority guidance documents, as applicable
  • Support the establishment of QC systems such as product specifications, product expiry, reference standard program, etc.
  • Develop and/or review QC documentation including SOP's, material specifications and other quality documents
  • In collaboration with Analytical Development, support method validation and method transfer activities
  • Support reference standard program
  • Apply strong technical writing and risk-management skills to address quality systems (e.g., OOS/OOTr, Deviations, Change Controls and CAPA's); collaborate with other quality teams
  • Contributes significantly and independently to project work which may include multiple projects within functional area
  • Additional responsibilities and ad hoc projects as required
  • Organization
  • Communication
  • Problem Solving/Critical Thinking
  • Judgement and Decision-making
  • Adaptability to work in fast-paced work environment Organization
  • Communication
  • Problem Solving/Critical Thinking
  • Judgement and Decision-making
  • Adaptability to work in fast-paced work environment Knowledge, Education, Experience & Skills:
    • BS with 6 years' experience required
    • 6+ years of quality control related experience
    • Experience working in QC lab environment with knowledge of international and national regulations and guidelines related to product testing; familiarity with ICH analytical and stability requirements
    • Strong experience in Cell base and analytical assays
    • Experience managing Contract Test Labs activities
    • Excellent communication skills and ability to build key networks and business relationships across all levels of the business Travel Commitment: Some Travel May Be Required

Keywords: Loves Furniture, Cambridge , Senior Manager, Quality Control Product Release and Stability, Executive , Cambridge, Massachusetts

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