Team Leader, QC

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Lead the Genexus QC weekend shift team while performing hands-on quality control testing to ensure high standards of product quality and regulatory compliance. As Team Leader QC youll oversee and participate in quality control testing of reagents and kits through various testing methods including next-generation sequencing and purification on the Genexus platform.

This is an on-site position. The shift will either be five 8-hour days Friday through Tuesday or four 10-hour days Friday through Monday.

What you will do:

• Lead and develop the Genexus QC weekend shift team while maintaining a hands-on role in testing operations
• Plan and perform quality control testing of reagents and kits using next-generation sequencing and purification methods on the Genexus platform
• Oversee and participate in Out of Specification (OOS) investigations including root cause analysis and corrective actions
• Initiate and manage problem reporting through TrackWise including deviations non-conformances failures and CAPA
• Lead updates to QC testing methods SOPs and batch record forms to align with current laboratory practices and continuous improvements
• Perform and oversee peer review of QC data packets to ensure data integrity and compliance
• Support product development programs method validation and process improvements
• Ensure the laboratory is well-stocked resourced and maintained in a safe tidy and efficient condition
• Foster a team-first mindset and ensure effective communication across shifts and functions
• Support method validation activities and technical documentation review
• Champion and promote Thermo Fishers 4 I values Integrity Intensity Innovation and Involvement
• Interface with cross-functional teams and management to drive quality excellence and operational efficiency
• Ensure all team members follow good laboratory practices cGMP requirements and safe working practices
• Manage weekend shift operations to support continuous manufacturing needs

• Bachelors Degree plus 2 years of experience in pharmaceutical/biotech QC laboratory operations
• 1 years of supervisory experience preferred
• 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 a fixed weekend schedule
• 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

PREFERRED QUALIFICATIONS

• Preferred Fields of Study: Chemistry Biology Biotechnology Pharmaceutical Sciences or related scientific field
• 1-2 years demonstrated leadership experience managing technical teams
• Industry certifications in GMP/GDP practices beneficial

Compensation and Benefits

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: Experience:

Manager