Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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.)

Job Description

Join a successful team at Thermo Fisher as a Quality Specialist II for Product Release and Label Management. Maintain quality programs and ensure devices meet quality standards before sale.

At the Specialty Diagnostic Group's Transplant Division, we support Thermo Fisher's Mission through healthcare solutions.

Perform product inspections as needed while also implementing conformance to specifications and reviewing production, packaging/labeling, and laboratory documents for final product releaseSystematically release finished and semi-finished product based on conformance to established standardsAssemble, lead, scan, and archive DHRs and ensure legibility and accuracy of electronic storageParticipate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problemsDevelop and support SOPs and train colleagues on SOPs as neededGenerate, identify, and suggest quality/process improvementsWrite and assist others in writing new or updated operating procedures and/or work instructionsShow initiative and ownership with assisting in document preparation/presentation for regulatory agency visits and Corporate/internal auditsProvide real-time support to Product Packaging and Labeling to prevent backorders, non-conforming materials release and adherence to the production scheduleMaintain quality, compliance, and safety following laws, policies, and guidelines with limited oversight.Complete all required trainings, attend GMP training and Implement strict compliance with procedures applicable to the role.This individual will exercise the highest level of integrity in all tasks performedIn a timely and prompt manner: identify, report, and seek correction for deviations noted in the workplace. Practice all behaviors in a safe and environmentally responsible manner

Minimum Qualifications

Bachelor’s degree or equivalent experience in a biological or related science from an accredited college or university2 years related QA or QC experience with a GMP regulated environmentPrevious experience reviewing and releasing batch records is also preferredExcellent analytical, prioritization, multi-tasking and interpersonal skills are requiredStrong initiative and capability to work independently without supervision are requiredCandidate must work constructively in cross-functional teams, demonstrating strong written and verbal communication skills.

Working Conditions/Physical Requirements:

Desk work, including long periods of sitting/standing in front of a 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