Quality Specialist II: Product Release and Label Management

Work Schedule

Environmental Conditions

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

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