Quality Engineer III - QA on the Floor (St Louis)

Job Title

St. Louis MO / Pharma Services Group

Our St Louis site is a lively biologic drug manufacturing facility with around 1k employees. The GMP facility focuses on cell process development for clinical and commercial manufacturing.

This is a non-supervisory role, reporting to the Manager of QA Operations at the Thermo Fisher St. Louis site. This position will be encouraged to work a shift schedule that includes weekend work.

Discover impactful work : This is your chance to define a tangible difference and be part of an exceptionally ambitious team!

What will you do? (Responsibilities)

• Spend the majority of work hours in manufacturing areas when production is on-going to coordinate activities from a quality perspective and provide QA-related input.
• Perform manufacturing batch record and documentation review with excellent attention to detail for completeness and accuracy prior to product release and / or closure.
• Perform QA approval of suite and equipment changeover between client processes.
• Perform autoclave logbook review and facilitate corrections.
• Observe active processing and be available to manufacturing and PE for support.
• Gemba all assigned areas daily and provide immediate feedback to colleagues and area management to ensure compliance with cGMP's, site procedures, and regulatory requirements.
• Perform quarterly Fit and Finish inspections.
• Block / unblock product and materials as needed.
• Perform monthly BSC observations.
• Attend and participate in daily QA OTF Tier 1 meetings.
• Take actions to develop one's own knowledge and skills.
• Perform all training requirements in a timely manner.
• Support QAD with Issue Print and Emergency Non-routine label printing on weekends and during off-shifts.
• Provide training, coaching, and mentorship to new and / or less experienced team members.
• Qualify new team members to perform tasks that require QSME training.
• Act as team leader in absence of supervisor.
• Effectively manage team's workload and delegate in absence of supervisor.
• Lead team meetings as needed.
• Write and review deviations in Trackwise as required.
• Author and review procedures in eDMS as required.
• Write and implement CAPA's as needed.
• Perform investigation interviews as required.
• Participate in interview process as vital.
• Members of this team need to acquire agreement and collaboration to address issues and uphold quality culture and standards in Operations without direct authority. Using tact and diplomacy is crucial with all customers.

Education and Experience

Knowledge, Skills, Abilities

Knowledge

Skills

Abilities

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Join us at Thermo Fisher Scientific to contribute to global health and safety.