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QC Supervisor - Finish Product job in High Point at Thermo Fisher Scientific

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QC Supervisor - Finish Product at Thermo Fisher Scientific

QC Supervisor - Finish Product

Thermo Fisher Scientific High Point, NC Full-Time

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

Pharmaceutical Services Group/ Soft Gel / Day Shift

Discover Impactful Work:

Directly supervises laboratory personnel in the area of scheduling lab testing and reviewing of analytical data for Raw Materials, Finished Products, In-Process, Stability, Microbiology, and non-production samples, including Cleaning Validation/Verification, Vendor Evaluation and Qualification samples aligned with established standards. Provides support through a leadership role within the QC Department to ensure that services and support to the manufacturing operations are efficient, effective and timely.

A day in the Life:

  • Ensure that the QC lab samples are tested in a timely manner to ensure on-time delivery for the site, and also ensure on-time testing of stability samples and review to meet regulatory commitments.

  • Provide batch disposition for raw materials, In-Process, Finished Product (Analytical & Microbiology) results in compliance with cGMPs and Banner policies and procedures.

  • Provide oversight of the stability program to include but not limited to: sample inventory management, scheduling stability samples for on-time testing, scheduling stability data for on-time review and reporting, tracking & trending of stability data, issuing and revising stability protocol, enrolling new samples in the stability program, issuing final stability reports to support APRs, recommending expiration dates for bulk and packaged products and scheduling routine PM/calibration for all the chambers.

  • Participate in Change Control processes as needed.

  • Provide data and information in response to external and internal audits/ regulatory Inspections.

  • Monitor production schedules and new product transfers for products that need to be included in the stability program.

  • Serve as Lead Investigators or provide support to Lead Investigators to conduct a broad spectrum of activities including troubleshooting, writing QC lab investigations related to testing to identify root causes and implementing appropriate Corrective/Preventative Actions (CAPAs).

  • Work collaboratively with other members of lab management to formulate and establish operating procedures and Work Instructions for QC employees.

  • Formulate and maintain Quality Control goals and objectives. complementary to corporate and plant policies and goals.

  • Interpret and adhere to all company policies and implement safety regulations for employees.

  • Provide technical support to analysts and technicians in the lab. Lead and train personnel in special test procedures, SOPs, equipment, and general laboratory guidelines.

  • Perform regular 1-on-1 coaching and conduct annual performance evaluations for subordinates and provide feedback for improvement.

  • Participate in ongoing training for the development of managerial and technical skills.

Education/Experience

Bachelors Degree in Chemistry, Microbiology, Biology, Biochemistry or related field, with at least 8 years of related experience in an analytical laboratory setting, or a Masters Degree with at least 6 years of related experience, or a Ph.D. with at least 4 years related lab experience or equivalent required.

Knowledge, Skills, Abilities

  • Knowledge in GMPs concepts, federal regulations, practices and procedures.

  • Able to read, analyze, and interpret common scientific instructions such as those written in Quality Control methods, specifications, procedures and USP methods.

  • Technical and operational knowledge in quality assurance and quality on the floor.

  • Knowledge and experience in analytical instrumentation HPLC, GC, IR, UV/VIS, dissolution and analytical methods.

  • Strong decision making skills.

  • Ability to work in a fast paced environment, able to be multi-task and results-oriented.

  • Ability to coordinate multiple activities while maintaining a high level of accuracy.

  • Outstanding attention to detail and organizational skills.

  • Self-starter, mature, independent and dependable.

  • Requires discretion and independent judgment.

  • Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by example set the example for others to follow

  • Effective and strategical communication skills written and verbal to interact with commercial operations at all levels.

  • High level of interpersonal skills to establish and maintain effective working relationships with employees and the customers; including tact to handle sensitive matters.

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 ([ Link removed ] - Click here to apply to QC Supervisor - Finish Product . 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.

Recommended Skills

  • Attention To Detail
  • Auditing
  • Biochemistry
  • Biology
  • Calibration
  • Chromatography
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