Quality Specialist II

Thermo Fisher Scientific • Franklin, MA

1d • $67,400 - $101,150

About The Position

As part of Thermo Fisher Scientific, the Quality Specialist II contributes to global healthcare and scientific advancement by supporting manufacturing operations across multiple product lines. The role ensures compliance with GMP standards, FDA regulations, and international quality requirements. In collaboration with cross-functional teams, the specialist implements continuous improvement initiatives, conducts investigations, and maintains quality management systems.

Requirements

• Bachelor's degree and at least 2 years of experience in pharmaceutical or biotech manufacturing, quality assurance, or a related GMP environment.
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements.
• Experience with quality management systems and documentation, such as TrackWise, Master Control, Documentum, or equivalent.
• Experience in deviation investigations, CAPA, change control, and root cause analysis.
• Proficiency in Microsoft Office 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 cold environments with exposure to dry ice and liquid nitrogen cryogenics, and to process and handle materials frozen on dry ice or liquid nitrogen.
• Ability to use personal protective equipment and adhere to safety protocols.
• Ability to stand and walk for extended periods and occasionally lift up to 25 pounds.
• Ability to work from 8 a.m. to 5 p.m., with additional hours as required.

Nice To Haves

• Additional language skills.
• Preferred fields of study include Biology, Chemistry, Engineering, Life Sciences, or a related scientific field.

Responsibilities

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements.
• Support manufacturing operations across multiple product lines.
• Implement continuous improvement initiatives with cross-functional teams.
• Conduct investigations, including deviation investigations, and support CAPA, change control, and root cause analysis.
• Maintain quality management systems and documentation.
• Support internal audits and external regulatory inspections.
• Handle materials frozen on dry ice or liquid nitrogen while following gowning and safety procedures.

Benefits

• 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 of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), which offers eligible colleagues the opportunity to purchase company stock at a discount.
• Variable annual bonus may be available based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level