Supervisor, QA

Saint Louis, MI - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

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 youll contribute to ensuring product quality and regulatory compliance. As a QA Supervisor youll lead and develop a team of quality professionals while overseeing quality operations including batch record review quality monitoring and continuous improvement initiatives. Youll 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.

What will you do

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 cGMPs 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 ones 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 CAPAs 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 Bachelors 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

Benefits & Total Rewards Thermo Fisher Scientific
Medical Dental & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement

OTHER

Relocation 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.

Required Experience:

Manager

Work ScheduleSecond Shift (Afternoons)Environmental ConditionsAdherence 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) req...