Quality Specialist II

while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

• ✓Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory

• ✓Experience with quality management systems and documentation (TrackWise, Master Control, Documentum, or equivalent)
• ✓Experience in deviation investigations, CAPA, change control, and root cause analysis
• ✓Proficient in Microsoft Office suite and quality management software systems
• ✓Technical writing and documentation skills
• ✓Analytical and problem-solving abilities
• ✓Clear verbal and written communication skills
• ✓Ability to work independently and collaboratively in cross-functional teams
• ✓Experience supporting internal audits and external regulatory inspections
• ✓Project management and organizational skills
• ✓Ability to work in warehouse environments and follow gowning procedures where required
• ✓Ability to work in a cold environment with exposure to dry ice and liquid nitrogen cryogenics
• ✓Must be able to process and handle materials frozen on dry ice or liquid nitrogen
• ✓Must use personal protective equipment and adhere to safety protocols
• ✓Additional language skills may be beneficial
• ✓Up to 10% travel may be required
• ✓Work schedule 8am-5pm, with additional hours as required
• ✓Physical

include standing/walking for extended periods and occasional lifting up to 25lbs

• ✓Bachelor's degree with minimum 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• ✓Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field

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