QC Microbiology Team Lead: GMP & Compliance Champion

ThermoFisher Scientific; Plainville (MA); On-site; USD 44,000 - 66,000; Full time

Benefits offered by this job

Annual incentive plan bonus

Healthcare

Employee Stock Purchase Plan

Job summary

Thermo Fisher Scientific seeks a Team Leader, QC to guide a quality control team in delivering compliant analytical testing and robust documentation. You will lead cross-functional efforts to implement GMP-aligned quality improvements and ensure timely testing across 24/7 schedules.

Responsibilities include mentoring staff, coordinating testing workflows, and interfacing with clients and regulatory bodies. Advanced degree or a degree with experience in pharma manufacturing is expected, with

Qualifications

• Advanced Degree, no prior experience required, or Bachelor's Degree plus 2 years of experience in pharmaceutical manufacturing and/or CDMO.
• Experience 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

Responsibilities

• Lead a quality control team in ensuring high standards of product quality and regulatory compliance.
• Collaborate with cross-functional teams to implement quality improvements and troubleshoot issues.
• Maintain rigorous GMP standards and meticulous documentation of results.
• Interface with clients and regulatory bodies as a subject matter expert in your area.
• Support and develop team members while ensuring efficient lab operations and timely testing

Skills

Leadership

Project management

Data integrity

Communication

GMP knowledge

Education

Advanced Degree

Bachelor's Degree

Tools

LIMS

MS Office

Statistical analysis tools

Job description

Thermo Fisher Scientific seeks a Team Leader, QC to guide a quality control team in delivering compliant analytical testing and robust documentation. You will lead cross-functional efforts to implement GMP-aligned quality improvements and ensure timely testing across 24/7 schedules.

Responsibilities include mentoring staff, coordinating testing workflows, and interfacing with clients and regulatory bodies. Advanced degree or a degree with experience in pharma manufacturing is expected, with