Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.
Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future.
Wed - Sa 2nd Shift Flexible (1pm - 11pm or 12pm - 10pm)
*How will you make an impact?*
This supervisor will be responsible for the Quality Control Contamination Control team for VVS by leading all aspects of and performing the Environmental Trending for the manufacturing area and facilities. This supervisor will lead all aspects of the investigations into Alert and Action level excursions throughout the facility. Additionally, this supervisor will coordinate the day-to-day project management of the team.
*What will you do?*
* Coordinate and schedule staff of Quality Control Microbiology Analysts.
* Author and implement investigations and change controls
* Author technical documents (SOPs, Gap Analyses)
* Provide training to junior level employees.
* Work closely with QC Management to develop training plans
* Represent QC Microbiology in departmental meetings
* Participate in recruiting and onboarding of new specialists
* Proactively assess environmental monitoring trends and develop mitigation plans as vital
* Act as a QC Microbiology SME during internal/external audits, risk assessments, and investigations
*How will you get here?*
This supervisor will deliver results by leading a high-performance team and completing projects on time with a high level of compliance and quality.
* BS (required) in Life Sciences or related field
* 3+ years of related industry experience, preferably in a GxP regulated setting.
* Extensive knowledge in microbiology.
*Knowledge, Skills, Abilities*
* Experience leading teams, training junior employees
* Experience writing deviations and investigations, crafting and revising Standard Operating Procedures
* Experience with electronic document management applications.
* Exposure to lab operations, client and regulatory inspections, basic lab safety and scientific processes associated with supporting QC laboratory functional areas.
* Understanding of GxP, GAMP, CFRs / Annex 11, Data Integrity as they relate to laboratory systems. Understanding of the Validation Lifecycle (GAMP 5).
* Understanding of applying SOPs, work instructions and regulatory requirements to managing instruments and equipment.
* Work independently and as a group on multiple projects at once.
* Be a liaison between departments
* Collaborate with Quality Assurance for review and approval of documentation.
* Detail oriented with strong verbal and written communication skills (e.g., technical and legible writing skills related to generating qualification documents, SOPs and work instructions, etc.).
* Ability to function in a dynamic environment and balance multiple priorities simultaneously.
* Ability to make decisions and work with minimal to moderate supervision.
At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.