Team Lead, QC Microbiology

ThermoFisher Scientific; Plainville (MA); On-site; USD 90,919,000 - 136,393,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off (PTO)

Tuition reimbursement

Employee stock purchase plan

Job summary

Thermo Fisher Scientific is seeking a Team Leader, QC to spearhead a quality control group and uphold GMP standards in a fast-paced pharmaceutical environment.

You will guide analytical testing, ensure regulatory compliance, and drive process improvements while coordinating with cross-functional teams and external stakeholders.

Qualifications

• Advanced degree; or Bachelor’s with 2 years pharma/CDMO experience.
• Experience in bioburden and endotoxin testing.
• Environmental monitoring in ISO 8/7/5 environments.
• GMP/GDP certifications beneficial.
• 1–2 years leadership experience preferred.
• Strong GMP, ICH, pharmacopeia knowledge.
• Proficiency with analytical instrumentation and testing methods.
• Experience with LIMS and quality documentation.
• Experience with process improvements and troubleshooting.
• Excellent project management and organizational skills.
• Strong interpersonal abilities to lead teams.
• Clear written and verbal communication, including technical writing.
• Proficiency with MS Office and statistical tools.
• Able to support 24/7 schedules.
• Attention to data integrity.
• Experience managing lab equipment calibration/maintenance.
• Knowledge of environmental monitoring and contamination control.
• Problem-solving in structured environment.
• English proficiency required; other languages beneficial.

Responsibilities

• Lead a quality control team and ensure high product quality and regulatory compliance.
• Collaborate with cross-functional teams to implement quality improvements.
• Troubleshoot technical issues and maintain rigorous GMP standards.
• Support and develop team members; ensure efficient lab operations and timely testing.
• Maintain meticulous documentation of results and interface with clients/regulatory bodies.

Skills

Leadership

Quality control

GMP

Regulatory compliance

Documentation

Project management

Communication

LIMS

Data analysis

Calibration

Education

Advanced degree

Bachelor's degree + 2 years pharma/CDMO

Tools

Analytical instrumentation

LIMS

Microsoft Office

Statistical analysis tools

Job description

Work Schedule

10 hr shift/days

Environmental 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, Office

Job 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!

• 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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.