Engineer/Scientist III, QC

West Hills, CA

Computer and Electronic Product Manufacturing

About the position

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. 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.

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.

Requirements

• 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.

Benefits

• 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.