Work Schedule

Environmental Conditions

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:
Guide quality assurance initiatives across manufacturing operations while supporting a culture of compliance and continuous improvement. Manage quality control processes, batch record review, deviation management, and regulatory compliance to ensure products meet the highest standards. Collaborate with cross-functional teams to investigate quality issues, implement corrective actions, and maintain strong relationships with customers and regulatory agencies. Support data integrity and GMP compliance while developing team members to achieve operational excellence and career growth.

The Quality Lab Supervisor assures the quality of laboratory data and reports through supervision of analytical review staff and performance of Quality Control (QC) reviews. Monitors consistency in interpretation of procedural requirements and the content of QC reports. Assures compliance with FDA Good Laboratory practices and/or GXP. The Quality Lab Supervisor will be able to assist with testing completion as priorities arise.

REQUIREMENTS:
• Advanced degree plus 3 years of experience, or Bachelor's degree plus 5 years of experience in pharmaceutical/biopharmaceutical quality assurance or quality control
• Preferred Fields of Study: Chemistry, Biology, Pharmacy, Engineering, or related scientific field
• Lead Auditor Certification from an accredited agency preferred
• Comprehensive knowledge of cGMP, FDA regulations, ISO standards and other relevant regulatory requirements
• Strong expertise in quality systems including deviation management, CAPA, change control, and batch record review
• Demonstrated leadership experience supervising quality teams
• Experience leading or participating in regulatory inspections and customer audits
• Demonstrated success in root cause analysis and quality investigations
• Advanced knowledge of quality risk management principles and tools
• Excellent project management and organizational skills
• Strong analytical and problem-solving abilities
• Superior written and verbal communication skills in English
• Proficiency with quality management systems and Microsoft Office applications
• Experience with statistical analysis and quality metrics reporting
• Ability to build collaborative relationships across functions
• Customer-focused mindset with strong business acumen
• Travel may be required to support audits and inspections

What You'll Do:
• Manage staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.
• Routinely interact with laboratory management regarding the priority of data and reports submitted to QC and assign work accordingly. Supervise QC staff, including scheduling, procedural interpretation, and performance evaluation.
• Oversee the implementation and continual improvement of QC processes. Serve in a leadership role through active participation in leadership team meetings.
• Consult with QC and laboratory staff to mediate disagreements that may arise. Monitor consistency in the interpretation of procedural requirements and the content of QC reports.
• Evaluate findings produced by QC staff and determine appropriate action. Identify issues that may require follow-up inspection. Report findings to laboratory staff and management.
• Participate in client and regulatory inspections, providing information regarding the QC program. Facilitate responses from the lab and retrieval of data.
• Act as on-site subject matter expert for root cause analysis or CAPA. Provide key input and recommendations for data review or investigation processes. Serve as a lead for client discussions regarding project quality or investigations/nonconformances as they relate to studies.

Knowledge, Skills, Abilities:
• Strong knowledge of SOPs and Federal Regulations to include GLP and GXP
• Strong knowledge of analytical methodologies, instrumentation and method validation
• Thorough knowledge divisional SOPs
• Excellent verbal and written communication skills
• Strong attention to detail
• Ability to deal with multiple and changing priorities
• Demonstrated leadership and time management skills
• Ability to train and mentor staff

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in an office or lab environment with exposure to electrical office equipment.