Quality Specialist II
About The Position
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers.
Requirements
- Thorough knowledge of FDA, EMA, and international GMP regulations
- Proven ability to review and approve GMP documentation, batch records, quality records, AQL Visual Inspection, Write Deviations, Change Control, CAPA closure, Metrics, PQR, and Daily Task.
- Strong understanding of quality management systems and tools (e.g. CAPA, change control)
- Excellent documentation and technical writing skills
- Proficiency with quality systems software and Microsoft Office applications
- Strong analytical and problem-solving abilities with 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
- Physical capability to stand, walk, and lift up to 25 pounds occasionally
- Sound judgment and decision-making skills
- Commitment to maintaining a quality-focused culture and driving continuous improvement
- Fluency in English required; additional language skills beneficial
- Availability to work on weekends
- Bachelor's Degree required, no prior experience required, preferably in a GMP manufacturing environment
Nice To Haves
- Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
- Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
