Lead QA Technician

Work Schedule

Environmental Conditions

Job Description

Job Title: Lead QA Technician Batch Record Review and Release (Quality Associate 4

Requisition ID:

At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fastgrowing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

St. Louis MO / Pharma Services Group

This is a nonsupervisory role reporting to the QA Supervisor Batch Record Review and Release at the Thermo Fisher St. Louis site.

Discover Impactful Work:

The Quality Assurance Batch Disposition Technician will be responsible for the of QA review and disposition of completed production batch records. This position requires a highly motivated selfstarter who can assimilate new information quickly and enjoys working closely with others within a fastpaced environment. The individual will perform activities required for dispositioning product while ensuring compliance with Thermo Fisher directives and procedures customer requirements and regulatory standards. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What will you do (Responsibilities)

• The QA Batch Disposition technician is responsible for of batch record disposition at the St. Louis facility.
• This individual will work closely with the Product Quality Lead team to ensure timely and compliant release of batches.
• Must be an excellent communicator collaborative and possess the ability to make sound timesensitive decisions.
• Complete quality review and closure of performed production batch records facilitating corrections and deviation initiation.
• Works collaboratively with manufacturing QC and crossfunctional team members to ensure results are met.
• Serve as QA approver/author for SOP revisions quality investigations and other required site documentation.
• Bachelors Degree (BA/BS) in Life Sciences (biology chemistry biochemistry) or other science related field.
• Associate degree with 2 years of experience with cell culture protein purification formulations or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
• History of establishing teams and interdepartmental relationships
• 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 knowledge is beneficial
• Experience with investigational writing software system (Track Wise) along with root cause analysis tools used in deviation investigations

Skills

• Analytical critical thinking and problem skills
• Strong written and oral communication skills
• Strong math skills

• Attention to detail
• Microsoft Office skills (especially Word and Excel)
  • Solid time management and organization skills

Abilities

• Able to understand and carry out instructions
• Multitask
• Ability to work efficiently in an environment of change
• Able to work independently

Physical Requirements / Work Environment

• 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
  

Benefits

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

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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