Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not Disclosed
- Location
- Plainville, Massachusetts, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Visa support
- “Must be legally authorized to work in the United States now and in the future, without sponsorship.”
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Role Summary
The Team Leader, QC leads quality control operations and supports product quality and regulatory compliance. The role oversees analytical testing and lab operations while supporting team development, quality improvements, and communication with clients and regulatory bodies.
What You'll Do
- Lead a quality control team in maintaining product quality and regulatory compliance.
- Support analytical testing and quality control operations.
- Work with cross-functional teams to implement quality improvements and troubleshoot technical issues.
- Support and develop team members.
- Ensure efficient lab operations, timely completion of testing, and documentation of results.
- Serve as a subject matter expert when interfacing with clients and regulatory bodies.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Required: an advanced degree with no prior experience, or a bachelor's degree plus 2 years of experience in pharmaceutical manufacturing and/or CDMO; experience in bioburden and endotoxin testing for pharmaceuticals and environmental monitoring in ISO 8, 7, and 5 environments; expert knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards; proficiency with analytical instrumentation and testing methods, LIMS, quality documentation, Microsoft Office, and statistical analysis tools; experience with process improvements, troubleshooting investigations, lab equipment, calibration, and maintenance; project management, organization, interpersonal, communication, technical writing, problem-solving, attention to detail, and data integrity skills; ability to work schedules supporting 24/7 operations; English proficiency.
Preferred
- Industry certifications in GMP/GDP practices are beneficial.
- 1-2 years demonstrated leadership experience managing technical teams preferred.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
10 hr shift/daysEnvironmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, OfficeJob Description
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.
DESCRIPTION:
Lead a quality control team in ensuring high standards of product quality and regulatory compliance at Thermo Fisher Scientific. As Team Leader, QC, you'll contribute to excellence in analytical testing and quality control operations while supporting our mission to enable customers to make the world healthier, cleaner and safer. Work with cross-functional teams to implement quality improvements, troubleshoot technical issues, and maintain rigorous GMP standards. Support and develop your team members while ensuring efficient lab operations, timely completion of testing, and meticulous documentation of results. Interface with clients and regulatory bodies as a subject matter expert in your area of focus.
REQUIREMENTS:
• Advanced Degree, no prior experience required, or Bachelor's Degree plus 2 years of experience in pharmaceutical manufacturing and or CDMO.
Eperience in Bioburden and endotoxin testing for pharmaceuticals
Experience in Environmental Monitoring in ISO 8, 7, and 5 Environments
• Industry certifications in GMP/GDP practices beneficial
• 1-2 years demonstrated leadership experience managing technical teams preferred.
• Expert knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards
• Strong technical proficiency with analytical instrumentation and testing methods
• Experience with laboratory information management systems (LIMS) and quality documentation
• Demonstrated success implementing process improvements and troubleshooting investigations
• Excellent project management and organizational skills
• Strong interpersonal abilities to lead teams and collaborate across functions
• Clear written and verbal communication skills, including technical writing
• Proficiency with Microsoft Office suite and statistical analysis tools
• Ability to work various schedules to support 24/7 operations
• Strong attention to detail and commitment to data integrity
• Experience managing lab equipment, calibration, and maintenance programs
• Knowledge of environmental monitoring and contamination control
• Demonstrated problem-solving abilities in a structured environment
• English proficiency required, additional languages beneficial
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
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, which includes a drug screening.
Compensation and Benefits
The hourly pay range estimated for this position based in Massachusetts is $31.73–$47.60.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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.