QA Operations Quality Specialist I
About The Position
As part of Thermo Fisher Scientific, the QA Operations Quality Specialist I supports manufacturing quality compliance and the company’s mission to make the world healthier, cleaner, and safer. The role provides quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. It helps maintain GMP compliance, investigate quality events, and drive continuous improvement while supporting delivery of products to customers. The position requires flexibility to work various shifts in support of manufacturing operations and the ability to gown and work in controlled manufacturing environments when needed. Work may involve cleanrooms, offices, cold rooms and freezers, and the use of personal protective equipment. Cleanroom restrictions include no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair.
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 attention to detail.
- Strong 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 and 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.
- Must be legally authorized to work in the United States now and in the future without sponsorship.
- Must be able 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 through documentation review and process monitoring.
- Review and approve GMP documentation, batch records, and quality records.
- Help maintain GMP compliance and quality management systems.
- Conduct quality investigations and root cause analysis.
- Collaborate with cross-functional teams.
- Support continuous improvement initiatives and a quality-focused culture.
Benefits
- Competitive remuneration.
- Variable annual incentive plan bonus, subject to company policy and performance results.
- 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).
- 10 paid holidays annually.
- Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
- Accident and life insurance.
- Short- and long-term disability in accordance with company policy.
- 401(k) retirement savings plan.
- Employee Stock Purchase Plan (ESPP) with an opportunity for eligible colleagues to purchase company stock at a discount.
- Career and development prospects.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
