Engineer/Scientist III, QC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

About Us: At Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you will have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make meaningful contributions to the world.

How will you make an impact:

Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Quality Scientist III/Engineer, QC will perform testing of Raw Material, Semi-finished, and Finished goods including data generation, product stability verification, product validation studies, data analysis and summarization, and other supporting activities.

Key Responsibilities:

• Ensure accuracy and completion of quality controlled records.
• Maintain testing logs and quality control records as per company policy.
• Perform routine QC functions, including equipment calibrations and managing lab supplies.
• Conduct product evaluation tests and support process improvements.
• Build and maintain databases for product performance and Key Performance Indicator metrics.
• Manage testing and disposition of product returns.
• Generate nonconformance reports and advise relevant parties.
• Lead or participate in team meetings to troubleshoot product issues.
• Coordinate assay troubleshooting and investigations of out-of-specification results.
• Lead new analytical method validations and transfers into the QC lab.
• Assist with product stability activities.
• Write and review method validation or stability protocols and reports.
• Review and approve QC test data.
• Plan and implement training for QC Associates.
• Serve as the primary QC representative for new product transfers.
• Coordinate and assign daily QC workload.
• Support other QC department functions as needed.

Qualifications:

• Bachelor Degree in biological or related sciences from an accredited college or university with 4 years of laboratory experience, or a Master's Degree with equivalent experience with 2 years of relevant laboratory experience.
• Proficient in MS Office (Word, Excel).
• Knowledge of GLP and GMP requirements.
• Basic understanding of Supply Chain and Quality Control.
• Strong interpersonal and communication skills.
• Ability to work optimally with cross-functional teams.
• Physical ability to lift, push, and pull 30-40 pounds consistently, and up to 50 pounds occasionally.
• Comfortable working in environments requiring personal protective equipment.

Accessibility/Disability Access: Thermo Fisher Scientific provides accommodations individuals with disabilities.

Apply Today: Join us and contribute to our mission. Apply at Thermo Fisher Careers.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.

Compensation and Benefits

The salary range estimated for this position based in California is $83,300.00–$125,000.00.

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