Supervisor, QA

Thermo Fisher Scientific•St. Louis, MO

2d•Onsite

About The Position

Join our Quality Assurance team at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. As a QA Supervisor, you'll lead and develop a team of quality professionals while overseeing quality operations including batch record review, quality monitoring, and continuous improvement initiatives. You'll collaborate with cross-functional teams to enhance quality excellence and maintain our high standards for product safety and compliance. This position offers the opportunity to contribute by helping ensure the quality of products that enable our customers to make the world healthier, cleaner and safer.

Requirements

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in a regulated manufacturing environment (pharmaceutical, medical device, or related industry)
2+ years of supervisory/leadership experience
Comprehensive knowledge of cGMP regulations, ISO standards, and quality systems
Strong understanding of quality risk management principles and tools
Experience with batch record review, deviation management, and CAPA systems
Demonstrated success in implementing quality improvements and leading change initiatives
Expertise in quality documentation systems and electronic quality management tools
Excellent project management and organizational skills
Strong analytical and problem-solving abilities
Excellent written and verbal communication skills
Ability to build relationships and collaborate across all organizational levels
Experience hosting regulatory inspections and customer audits
Proficiency with quality management software systems (e.g., TrackWise, SAP)
Comprehensive understanding of validation principles and requirements
Demonstrated ability to support quality culture and continuous improvement
Experience developing and delivering quality-related training
Strong decision-making skills with focus on risk-based approaches
Ability to effectively manage multiple responsibilities in a deadline-oriented environment
Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
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.

Nice To Haves

Professional certifications (e.g., CQE, ASQ) desirable
Preferred Fields of Study: Biology, Chemistry, Engineering

Responsibilities

Oversee, supervise, and ensure the successful day-to-day operations of the Quality on the floor team.
Sets objectives and tasks for staff and regularly review staff progress in regular meetings.
Spend the majority of work hours in manufacturing areas supporting active processing and working closely with Manufacturing and Process Engineering to oversee activities from a quality perspective and provide QA-related input
Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections
Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
Perform QA approval of suite and equipment changeover between client processes
Perform autoclave logbook review and facilitate corrections
Perform Fit and Finish inspections per the risk assessment and guiding procedures
Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets
Attend and actively participate in MFG huddles
Lead/attend and actively participate in QA OTF Tier 1 huddles
Act as Quality Management Representative for the company as needed
Take actions to develop one’s own knowledge and skills
Perform all training requirements in a timely manner
Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies
Qualify new team members to perform tasks that require QSME training
Write and review deviations in Trackwise as required
Author, revise, and review procedures in eDMS as required
Write and implement CAPA’s as needed
Conduct/participate in investigation interviews/RAPIDs as required
Individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.