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
Compensation and Benefits
The hourly pay range estimated for this position based in Maryland is $25.60-$38.40.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
