Work Schedule10 hr shift/days
Environmental ConditionsLaboratory Setting
Job DescriptionLocation/Division Specific InformationOn site - St. Louis, Missouri Drug Substance Division
This role is based at PSG STL site.
How will you make an impact?Position Summary and Key ResponsibilitiesWe need a dedicated and experienced Quality Control Supervisor for our microbiology group. You will be responsible for supervising a portion of the microbiology team to developing, implementting, and maintainning Quality Assurance and Quality Control processes to ensure compliance with customer and regulatory requirements.
The role involves leading a team of microbiologists and Quality Control analysts. They will provide support for analytical testing, development, validation, and troubleshooting of microbiology products.
What will you do? - Provide technical support to the microbiology Quality Control team.
- Provide Quality leadership by developing and empowering staff, encouraging relationships, putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals.
- Mentor and train the Quality team to provide the best possible service through effective communication, scientific leadership, and problem-solving.
- Lead a culture of quality awareness, teamwork, and compliance.
- Provide daily mentorship and timely support for problem requests, complaint records, deviations, invalids, corrective and preventive actions, and change controls to ensure closure in a scientifically sound manner.
- Maintain and update departmental documentation (SOPs, technical documents), providing input on revisions as needed.
- Responsible for creation, management, and adherence to Quality procedures.
- Drive operational performance by identification, monitoring, and trending of quality metrics.
- Enable good working relationships with all business partners.
- Collaborate across functions and sites to troubleshoot problems, interpret data, and resolve next steps based on a risk-based approach.
- Offer mentorship and direction to ensure ISO/Quality Management System compliance.
- Ensure personnel receive comprehensive training (skills-based, cGMP, safety) to support clinical and commercial production needs.
- Perform additional duties as directed by the Manager.
How will you get here?- A bachelor's or equivalent experience in biology is required, Microbiology degree is preferred along with supervisory experience.
- Knowledge, Skills, Abilities
- Proficient knowledge of microbiology, particularly in troubleshooting and analytical transfer of microbiological assays.
- Experience in working with microbial identification and antibiotic susceptibility testing is desired.
- Proven ability to think critically and innovatively combined with a willingness to challenge.
- Demonstrated ability in troubleshooting and solving complex issues.
- Demonstrated expertise in the regulatory and compliance requirements for microbiological methods and specifications, including a solid understanding of ICH, FDA/EMA guidelines, and USP, PH. Eur, or equivalent experience.
- Excellent technical writing skills and verbal communication are required to interact with all levels of our organization and clients.
- Ability to work with cross-functional teams and engage with employees and customers at all levels.
- Adopt and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business.
BenefitsWe offer competitive remuneration, 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!
OtherRelocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
