QA Operations Quality Specialist I

Thermo Fisher Scientific • Plainville, MA

22h

About The Position

As part of Thermo Fisher Scientific, the QA Operations Quality Specialist I provides quality oversight across manufacturing operations to help ensure compliance and support the company’s mission. The role involves detailed documentation review, process monitoring, collaboration with cross-functional teams, maintaining GMP compliance, investigating quality events, and supporting continuous improvement initiatives. The position works in a collaborative environment focused on delivering life-changing products.

The work schedule is a flexible 12-hour shift, with days indicated. Work may take place in a cleanroom, cold rooms or freezers, and an office. Cleanroom restrictions prohibit hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair. Personal protective equipment may be required, including safety glasses, gowns, gloves, lab coats, and ear plugs. The role requires the ability to gown and work in controlled manufacturing environments when needed, and to stand, walk, and occasionally lift up to 25 pounds.

Candidates must be legally authorized to work in the United States now and in the future without sponsorship and must pass a comprehensive background check, including drug screening. Relocation assistance is not provided. The estimated hourly pay range in Massachusetts is $26.39–$39.59, with possible eligibility for a variable annual bonus based on company, team, and/or individual performance.

Requirements

• Bachelor’s degree required.
• At least 1 year of experience required, preferably in a GMP manufacturing environment.
• Thorough knowledge of FDA, EMA, and international GMP regulations.
• Proven ability to review and approve GMP documentation, batch records, and quality records.
• Strong understanding of quality management systems and tools, such as CAPA and change control.
• Excellent documentation and technical writing skills.
• Proficiency with quality systems software and Microsoft Office applications.
• Strong analytical and problem-solving abilities and keen attention to detail.
• Outstanding verbal and written communication skills.
• Ability to work independently and collaborate effectively across functions.
• Experience conducting quality investigations and root cause analysis.
• Knowledge of environmental monitoring and contamination control principles.
• Flexibility to work various shifts as needed to support manufacturing operations.
• Ability to gown and work in controlled manufacturing environments when required.
• Ability to stand, walk, and occasionally lift up to 25 pounds.
• Sound judgment and decision-making skills.
• Commitment to maintaining a quality-focused culture and driving continuous improvement.
• Fluency in English.
• Legal authorization to work in the United States now and in the future without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Nice To Haves

• Preferred fields of study include Chemistry, Biology, Engineering, Life Sciences, or a related scientific field.
• Relevant certifications, such as ISO auditor or Six Sigma, are advantageous.
• Additional language skills are beneficial.

Responsibilities

• Provide quality oversight across manufacturing operations.
• Review and approve GMP documentation, batch records, and quality records.
• Monitor processes and support GMP compliance.
• Investigate quality events and conduct root cause analysis.
• Collaborate with cross-functional teams.
• Support continuous improvement initiatives.
• Work in controlled manufacturing environments and gown when required.

Benefits

• Competitive remuneration and potential variable annual incentive bonus.
• 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: 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 offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

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