The primary purpose of this position is to provide direct quality support to ensure
compliance with regulations that govern pharmaceuticals. Full compliance ensures
Thermofisher can operate without regulatory actions that impede product quality, cause
product stoppages, or reduce customer satisfaction.
This Quality Assurance Floor Support position is for night shift 12 hour rotation.
The position specifically provides support and oversight for Oral Solid Dosage Manufacturing/Packaging and Animal Health operations.
Key Areas of Accountability / Responsibility:
1. Comply with all job-related safety and other training requirements. It is the
responsibility of each employee to work in a safe and responsible manner in order
to create an injury-free and incident-free workplace.
2. For processes and projects of low to moderate complexity, perform compliance
assessments, make decisions regarding regulatory requirements; ensure
adherence to current regulations with little dependence on others.
3. Provide leadership and team participation as assigned for assignments related to
quality initiatives and compliance improvements, product transfers, facility
4. Perform document reviews and made determinations as to whether work
performed meets current procedures and regulatory expectations. Communicate
and coordinate with other departments as required to resolve issues and
compliance concerns detected during review.
5. Conduct risk assessments and take appropriate actions during quality oversight
activities (e.g. during review/approval) to ensure adequate controls in relation to
the level of product quality, safety and business risks.
6. Comply with all job-related safety and other training requirements.
7. Other duties as assigned.
Knowledge and educational level:
BS in related field plus 2 years of relevant experience.
OR MS in related field (Computer science, Chemistry, Biology, or other technical or
OR AAS with 3 years of relevant experience
OR 4 years of relevant experience.
Thorough knowledge of GMPs as detailed in 21CFR Parts 210 and 211 and
associated guidance documents.
Multiple computer skills including working experience with MS Office applications
such as Word and Excel and general experience in computer systems associated
with quality assurance functions such as lot review, SAP material movement verification, Trackwise queries and trending, SOP review and approval, lab
results reviews (LIMS), disposition of product and validation document reviews.
Required level of experiences:
2-4 years related field experience dependent upon level of education.
Experience in reviewing technical and scientific data associated with
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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.