• Sr. Manager QC

    ThermoFisher Scientific (Middletown, VA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

     

    Location/Division Specific Information

     

    The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the IVD industry for over 40 years. The division provides products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening and more.

    Discover Impactful Work:

    As part of the Middletown, VA team, some of the world’s largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing partner. With over 35 years of experience, customers count on us for quality, compliance, and reliability.

     

    A day in the Life:

    + Develop appropriate strategies for the success of the Quality Control Operations in support of the current, expanding and emerging business.

    + Lead and manage a Quality Control team overseeing raw material management and product release testing.

    + Leverage CDD and SDG sites in improving QC policies and procedures.

    + Identify expertise gaps in the current staff, coach, mentor, and develop team Leaders and members, fostering a culture of continuous learning.

    + Establish QC metrics, analyze data trends, and drive initiatives for departmental improvements.

    + Collaborate with cross-functional teams to implement processes that would eliminate risk of conflict in qualification /validations of Test methods.

    + Drive the adoption of Electronic Systems to support QC operations.

    + Design and implement analytical tools and techniques to ensure the delivery of high-quality products.

    + Present QC testing failures and Out of Specification investigations to clients/customers.

    + Adhere to all regulatory and in-house requirements, including safety, housekeeping, laboratory chemical waste, cGMP, GDP, and documentation, when performing assigned activities.

    + Exhibit professional behavior with both internal and external business associates, reflecting positively on the company and aligning with its policies and practices.

    Education/Qualifications:

    + Degree (BS) in Biochemistry, Microbiology, Molecular Biology, Pharmaceutical Sciences, or related field.

    + 7+ years’ experience within regulated industry/ hospital setting.

    + 5+ Years of experience managing QC/ Testing team.

    + Experience in a cGMP environment is required.

    + Knowledge and use of Good Documentation practices is required.

    + An ability to learn quickly and make sound, scientifically driven decisions that adhere to regulatory practices is required.

    + Experience with internal, external, and customer audits.

    + Experience with JD Edwards and Lab Info Management System is a plus.

     

    Benefits

     

    We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

     

    Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.