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Thermo Fisher Scientific · 3 hours ago

Lead QA Technician

St Louis, MO

Full-time

Onsite

Senior Level

5+ years exp

Thermo Fisher Scientific is an innovative organization in the life sciences sector, and they are seeking a Lead QA Technician to ensure quality assurance in manufacturing processes. The role involves overseeing quality-related activities, performing documentation reviews, and providing support to manufacturing teams to maintain compliance with regulatory standards.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

U.S. Citizen Only

Responsibilities

Spend the majority of work hours in manufacturing areas when production is on-going to oversee activities from a quality perspective and provide QA-related input

Perform manufacturing batch record and documentation review with excellent attention to details 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 necessary

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

CGMP experienceQuality practices knowledgeAnalytical skillsTrackwise experienceCell culture experienceProtein purificationMath skillsMicrosoft Office skillsInterpersonal skillsWritten communicationOral communicationAttention to detailTime management skills

Required

High school degree and five (5) years of experience working in Quality required

Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry) or other science related field combined with a minimum of three (3) years of relevant experience required

Experience in cGMP or other highly regulated industry required

Understanding ‘why' and not just the ‘how' of processes and practices

Knowledge of Quality practices and cGMP regulations and other international health authority guidelines

Analytical, critical thinking, and problem skills

Strong interpersonal skills

Strong written and oral communication skills

Strong math skills

Strong attention to detail

Strong Microsoft Office skills (especially Word and Excel)

Solid time management and organization skills

Understand and carry out instructions

Effectively multi-task

Work effectively in a dynamic environment

Able to work under pressure

Able to work independently

Demonstrated ability to lead others

Able to coordinate workload for junior team members

Able to understand departmental as well as site priorities

Ability to collaborate with colleagues at all levels of organization

Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.- Able to gown, wear PPE, and work successfully in a clean room environment

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

Preferred

Two years of experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is highly preferred

Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements

Tech transfer experience is a plus

Experience with investigational writing software system is a plus (Track Wise) along with root cause analysis tools utilized in deviation investigations