Quality Specialist II: Product Release and Label Management

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

At the Specialty Diagnostic Group's Transplant Division, we support Thermo Fisher's Mission to improve patient experience 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 release
• Systematically release finished and semi-finished product based on conformance to established standards
• Assemble, lead, scan, and archive DHRs and ensure legibility and accuracy of electronic storage
• Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
• Develop and support SOPs and train colleagues on SOPs as needed
• Generate, identify, and suggest quality/lean process improvements
• Write and assist others in writing new or updated operating procedures and/or work instructions
• Show initiative and ownership with assisting in document preparation/presentation for regulatory agency visits and Corporate/internal audits
• Provide real-time support to Product Packaging and Labeling to prevent backorders, non-conforming materials release and adherence to the production schedule
• Maintain 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 performed
• In 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 High School diploma with 5 years of validated experience in a biological or related science from an accredited college or university
• 3 years related QA or QC experience with a GMP regulated environment
• Previous experience reviewing and releasing batch records is also preferred
• Excellent analytical, prioritization, multi-tasking and interpersonal communication are required
• Strong initiative and capability to work independently without supervision are required
• Candidate 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