Lead QA Technician

Location: St Louis

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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, Cold Room/Freezers
-22degrees

F/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Lead QA Technician is a quality assurance professional with substantial prior experience of working within a Quality organization in a highly regulated industry. This individual specializes in deviation prevention by executing QA on-the-floor activities that include but are not limited to in-process batch record review, logbook review, GEMBAs of all manufacturing areas, providing feedback to colleagues, observing active processes, supporting Manufacturing and PE by providing Quality input as needed, and requesting the initiation of deviations as they are identified.

All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What will you do? (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.

Education and Experience
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
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

Knowledge, Skills, Abilities

Knowledge
Understanding ‘why’ and not just the ‘how’ of processes and practices
Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
Tech transfer…