Work Schedule
Second Shift (Afternoons)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
How will you make an impact?
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.
• 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.
Keys to Success:
• 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)
• Preferred Fields of Study: Biology, Chemistry, Engineering
• Professional certifications (e.g., CQE, ASQ) desirable
• 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
Excellent Benefits
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