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Lead QA Technician
ThermoFisher Scientific • Rockville, MD 20851 • Posted 3 days ago
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In-person • Full-time • Senior Level
Job Highlights
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The Lead QA Technician at ThermoFisher Scientific conducts critical reviews of GMP documentation associated with materials control, ensuring compliance with batch records, departmental SOPs, GMP, and DEA regulations. This role involves reviewing online batch records, approving and controlling labels, resolving discrepancies, and hosting audits. The position requires a bachelor's degree in a life sciences discipline, with a preference for candidates with over 5 years' experience in the biological, biopharmaceutical, or regulated pharmaceutical industry.
Responsibilities
- Conducts critical reviews of GMP documentation associated with materials control.
- Ensure all activities are in accordance with the batch records, departmental SOPs, GMP and DEA regulations.
- Review online batch records for completeness of signatures, entries, and material reconciliation.
- Approve and control labels.
- Review documents completed by operations personnel.
- Resolve production/QC and documentation discrepancies.
- Respond to inquiries on quality control activities and schedules.
- Collect and trend Quality Control Data and maintain the QC Shipping & Receiving Logs.
- Host internal and external audits, provide timely CAPA plans in response to any audit observations, and track CAPAs to completion.
- Perform other duties as assigned to meet business needs.
Qualifications
Required
- Bachelor's degree in a life sciences discipline.
- Thorough knowledge of cGMPs, 21 CFR, Part 210/211/600s, USP and ICH guidelines.
- 2+ years' experience in QA/QC function.
Preferred
- 5+ years' experience within biological, biopharmaceutical, or regulated pharmaceutical industry.
About ThermoFisher Scientific
Thermo Fisher Scientific is a multinational biotechnology company that provides a wide range of products and services in the scientific research and diagnostics industry. They offer scientific instruments, laboratory equipment, diagnostic testing solutions, and more to customers worldwide in industries such as pharmaceuticals, biotechnology, healthcare, academia, and environmental research. Thermo Fisher Scientific is known for its high-quality products, robust R&D capabilities, and strategic acquisitions that have solidified its position as a leader in the market.
Full Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Conducts critical reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records) by exercising judgment within defined procedures and regulations.
Assure all activities are in accordance with the batch records, departmental SOPs, GMP and DEA regulations.
Review of online batch records in terms of completeness of signatures, entries, and material reconciliation.
Approves and controls labels.
Reviews documents completed by operations personnel
Resolves production/QC and documentation discrepancies.
Responds to inquiries on quality control activities and schedules in general.
Collects and trends Quality Control Data and maintains the QC Shipping & Receiving Logs.
Host internal and external audits, provide timely CAPA plans in response to any audit observations, and track CAPAs to completion.
Other duties may be assigned to meet business needs.
Education/Experience:
+ Requires a bachelor's degree in a life sciences discipline
+ Prefer 5+ years' experience within biological, biopharmaceutical, or regulated pharmaceutical industry
+ 2+ years' experience in QA/QC function
+ Requires thorough knowledge of cGMPs, 21 CFR, Part 210/211/600s, USP and ICH guidelines.
At Thermo Fisher Scientific, we are committed to creating a workplace where diversity and inclusion are valued. We believe that bringing together individuals with different experiences, backgrounds, and perspectives leads to innovative solutions and better outcomes for our customers. As an equal opportunity employer, we strictly prohibit discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
We also offer accessibility services for job seekers requiring accommodations in the application process. If you require assistance due to a disability, please contact us at 1-855-471-2255* to request an accommodation.
**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!
**For more information on our benefits, please visit:** **https://jobs.thermofisher.com/global/en/total-rewards**
Join our team and be a part of our mission to make the world healthier, cleaner, and safer. Apply today at http://jobs.thermofisher.com (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.
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