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.
This position is a manufacturing lead/specialist who works on resolving quality issues, driving manufacturing improvements and leading team of chemists as needed to meet the production schedule. May manufacture complex products and completes associated documentation. Contributes to the transfer of new products into Production. Participates and Leads Practical Process Improvement.
- Manufactures complex products following cGMP and completes all necessary documentation in accordance with quality system.
- Serves as back-up to supervisor for all department activities and has decision making and signature authority in the absence of supervisor.
- Leads and manages the team’s daily accountability and management boards.
- Attends required meeting (e.g. New Product Development, Design control, scheduling, etc.) as department representative.
- Resolves department NCAR and CAPA.
- Performs in-process assays using clinical analyzers. Review and analyze data. May perform product filtrations.
- Performs inventory transactions using MRP system.
- Provides direction, coordination, training and mentoring for all chemists, associate chemist, and associates.
- Writes, reviews, and modifies SOPs, work instructions, and reports.
- Reviews and approves completed batch records.
- Writes and executes validation protocols for equipment or processes.
- Has great technical knowledge of products and works with other departments to troubleshoot process and procedures and recommend solutions.
- Keeps department supervisor or manager updated on all issues.
- Maintain and analyze lot histories for trends and discrepancies.
- Leads PPI, Lean, and 5-S programs.
- Perform other job duties as required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle or feel objects, tools, or controls; talk and hear; and smell.
- The employee frequently is required to reach with hands and arms and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 50 pounds.
- BS/BA in scientific discipline (biology/biochemistry) with minimum of 5-10 years of related experience.
- Demonstrated leadership abilities with projects and/or teams.
- Strong understanding of Quality System Regulations, cGMP, and ISO; experience with NCAR and CAPA.
- Strong interpersonal skills.
- Experienced in working with potentially hazardous chemicals and human source materials.
- Experience manufacturing In-Vitro Diagnostic (IVD) quality control products a plus.
At Thermo Fisher Scientific, each one of our 50,000 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.