When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. ​With our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers.

How will you make an impact?

Within the Quality organization of the Chelmsford, MA facility, we are seeking a career-conscious Quality Control Supervisor who will be motivated by this exciting opportunity for an experienced Quality Professional to lead and grow a POROS workstream team to meet the needs of multiple businesses including one that is fast-growing.

You’ll be a proven team leader with experience in building high-performance teams, bringing a strong operational understanding and technical expertise to enhance our Quality Team.

What will you do?

Supporting the Quality Organization, the Quality Control Supervisor will:

• Reporting into the QC Manager, the QC Supervisor will lead and manage the (Poros Workstream Team) responsible for In-Process, Product Release, Stability testing as well as process improvement activities.

• Understand Customer needs and Operational requirements essential for delivering quality product on time.
• Adhere to in-house processes and procedures while maintaining compliance to ISO 13485 standards.
• Provide guidance and expertise to Poros Workstream QC Operations personnel by coaching, mentoring, and developing people and by fostering a culture of learning,
• Oversee (OOS) Out of Specification investigations and general troubleshooting with an effort towards timely resolutions.
• Take initiatives to improve lab efficiency by monitoring KPI’s and expedite overall organization.
• Partner with cross-functional team members to drive and execute critical quality attributes, cross-functional and cross-site initiatives.
• Develop and execute a resource plan to support business sustainability, risk mitigation and growth.
• Utilize leadership skills in maintaining and supporting a safe and quality culture.

How will you get here?

Education and Experience

• Bachelor’s or equivalent degree from accredited college/university in relevant scientific discipline and have a strong leadership and technical background. Preferred advanced degree i.e., Masters or Doctorate.
• Minimum 5 years of relevant Quality Control Lab experience.
• Experience training to Quality Control and other staff.
• Experience with internal and customer audits.
• Demonstrated leadership skills.

Knowledge, Skills, Abilities

• Knowledge of Quality standard (e.g., ISO 13485), FDA, ICH (International Council for Harmonization) Quality guidelines.
• Working knowledge of HPLCs, UV, FTIR and other analytical equipment.
• Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, Deviation investigation and Change Control process.
• Document review experience such as, but not limited to, in-process, final batch release and stability data.
• Understanding of how to set up and maintain product stability programs and sample/raw material retain programs.
• Familiarity with SAP, Trackwise, Agile, E1, LIMS systems
• Ability to work independently or as part of a team.
• Flexibility to adapt to a dynamic environment and manage activities to meet the needs of the business while maintaining a focus on Quality.
• Versed in continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.
• Excellent inter-personal, communication and organizational skills with good attention to detail.
• Ability to produce and present original quality communication materials for internal and external audiences.
• Must be able to commute between our Bedford and Chelmsford facility.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.