Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

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

Requisition ID:

At Thermo Fisher Scientific team, you’ll 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 COVID-19 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 fast-growing, 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 non-supervisory 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 execution of QA review and disposition of completed production batch records. This position requires a highly motivated self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced 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 execution 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, time-sensitive decisions.Complete quality review and closure of performed production batch records – facilitating corrections and deviation initiation.Works collaboratively with manufacturing, QC, and cross-functional team members to ensure results are met.Serve as QA approver/author for SOP revisions, quality investigations, and other required site documentation.Bachelor’s 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 preferredHistory of establishing teams and interdepartmental relationshipsCleanroom 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 practicesKnowledge of Quality practices and cGMP regulations and other international health authority guidelinesTech transfer knowledge is beneficialExperience with investigational writing software system (Track Wise) along with root cause analysis tools used in deviation investigations

Skills

Analytical, critical thinking, and problem skillsStrong written and oral communication skillsStrong math skillsAttention to detailMicrosoft Office skills (especially Word and Excel)Solid time management and organization skills

Abilities

Able to understand and carry out instructionsMulti-taskAbility to work efficiently in an environment of changeAble 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, forward-thinking 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 100,000+ 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! http://jobs.thermofisher.com

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.
 

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
 

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.