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Thermo Fisher Scientific · 9 hours ago

Supervisor, QA

St Louis, MO

Full-time

Onsite

Senior Level

5+ years exp

Thermo Fisher Scientific is seeking a QA Supervisor to lead their Quality Assurance team. In this role, you will oversee quality operations, ensure product quality and regulatory compliance, and mentor a team of quality professionals while collaborating with cross-functional teams to enhance quality excellence.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

Quality AssuranceCGMP regulationsISO standardsDeviation managementCAPA systemsQuality risk managementQuality management softwareAnalytical skillsTrainingProject managementCommunication skillsLeadership experienceMentorship

Required

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