Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

Want to make a difference? Become a part of a successful and respected team within Thermo Fisher! This quality systems position will maintain quality systems programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale. This role will also be responsible to ensure that controlled quality documents including non-conformances, deviation, and Supplier Corrective Action (SCAR) documents are maintained in an organized manner and able to be referenced quickly for compliance purposes.

In the Specialty Diagnostic Group, we help Thermo Fisher achieve its Mission by enabling human healthcare. Across our six divisions, we offer a range of diagnostic test kits, reagents, culture media, instruments and associated products to serve customers in healthcare, clinical, pharmaceutical, industrial and food safety laboratories. At the West Hills site, we prioritize a dedication to improving the quality of life of transplant patients and their loved ones by developing and producing innovative, high quality HLA products for the clinical and research segments of the transplant community.

Position Summary

The Quality Specialist II will handle/address/track quality issues that arise from Non-Conformance (NCR) Deviation or SCAR. This position will assist the QS Manager and operations with corrections to ensure timely and effective completion of required activities.

The duties and responsibilities include, but are not limited to the following:

• Responsible for resolving non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory).
• Assembles information from multiple departments in order to resolve risk related to a reported Nonconformance.
• Responsible for the assignment of SCAR reports from NCs.
• Ensure all nonconforming product(s) are identified and removed from use.
• Ensure completion and accuracy of all associated quality records related to NC, Deviation and SCAR.
• Assist with the performance and documentation of Internal Audits and support External Audits, as required.
• Lead and/or participate in product related team meetings and/or performance reviews, as needed.
• Perform additional administrative and/or clerical duties for department as bandwidth allows.
• Perform computer operations for data entry, and provide tracking/trending reports.
• Additional support of routine QA department standard operating procedures (SOPs) is also encouraged when possible.

Minimum Qualifications:

• Bachelor’s degree in Biological Sciences or a related field
• Two (2) years of validated experience in a Quality regulated environment
• Able to build presentations, work with spreadsheets, prepare reports and write procedures applying MS Word, Excel and PowerPoint software applications, SAP experience is a plus.

Knowledge of:

Detailed knowledge of ISO and GMP associated with medical device and diagnostics manufacturing, statistical process controls and GMP/CAPA requirements.

Ability to:

• Provide accurate QS tracking and trending reports.
• Good procedural writing skills encouraged.
• Exercise independent discretion and judgment in execution of duties.
• Plan and coordinate oneself in a consistent manner.
• Be a self-starter with the ability to positively empower others in a coordinated fashion.
• Establish and maintain effective working environment with staff members.
• Efficiently communicate both orally and in writing to management, customers and regulatory personnel.
• Maintain confidentiality of critical laboratory information

Working Conditions/Physical Requirements:

Desk work, including long periods of sitting/standing in front of PC. Non-remote.

Compensation and Benefits

The salary range estimated for this position based in California is $66,000.00–$99,000.00.

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