Sr. Manager QC

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team youll 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 worlds 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 100000 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.