Lead Batch Record Review and Release Technician
3 weeks ago
Job Title: Lead QA Technician - Batch Record Review and Release (Quality Associate 4)
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 executed 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 in support of 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. The incumbent must be an excellent communicator, collaborative and possess the ability to make sound, time-sensitive decisions.
- Execute quality review and closure of executed production batch records - facilitating corrections and deviation initiation.
- Works collaboratively with manufacturing, QC, and cross-functional stakeholders to ensure deliverables are met.
- Serve as QA approver/author for SOP revisions, quality investigations, and other required site documentation.
- Associates Degree with 2 years of experience
- Bachelors of Science with 0 years of experience.
- Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements
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 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
- Analytical, critical thinking, and problem 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
- Able to understand and carry out instructions
- Effectively multi-task
- Able to work effectively in an environment of change
- Able to work independently
- 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
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
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 *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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