Shire Jobs

Job Description

The Advanced Cell Systems QC team at Thermo Fisher Scientific is responsible for testing various primary tissue and organ-derived products, including media and all aspects of primary cell products such as embryonic neurons and RNA. The team is dynamic and fast-paced, relying on teamwork, multitasking, and communication within the larger organization. Therefore, we seek an energetic individual with strong communication, technical, and operational skills to join the team. The candidate will be a quality control supervisor and ensure the team follows SOPs and aligns with EH&S, Quality, and any other required manufacturing or company systems (E1, Agile, Trackwise, etc.). Under indirect supervision, responsible for generating high-quality products. Ability to identify and address quality issues and report to the supervisor any possible deviation from approved processes. Ability to use and troubleshoot processes in daily duties. They are directly involved in collateral activities such as Kaizen, 5S, inventory management, cycle counting, etc. Adopt a positive attitude that chips into a healthy work environment and the development of an impactful work team.

The supervisor’s duties include staffing, employee mentoring and development, performance management, training, and scheduling. In addition, the supervisor handles all QC/QA reporting for a functional group, timekeeping, on-call scheduling, and other duties assigned by the Manager. The supervisor leads all aspects of the activities of all laboratory personnel to ensure production according to our Standard Operating Procedures. The supervisor must also be cross-trained and train others in Cell QC. Will ensure coverage for employees due to vacations/sick time. The supervisor works in a team-based environment to QC cell products in the life sciences industry. Implement QC schedule and coordinate with GI group for lot release. Actively participate in New Product Development and Introduction, process improvement, and team management and coordinate with other groups.

Essential Functions

• Manages QC/QA, supply chain, RM, and FG supply through E1 management systems.

• Advise the team's overall QC testing (products and/or services) activities to ensure timely delivery of projects or products to customers.

• Direct supervision and participation in QC work, including cell culture, analytical methods, and reagent preparations.

• Demonstrate a basic understanding of scientific principles and cellular biology.

• Provides support to team members, including presenting team goals and identifying areas for new training or skill checks

• Engages in the hiring processes and new team member training.

• Supports department manager and performs management duties when manager is absent or out of office

• Answers team member questions, helps with team member problems and leads all aspects of team member work for quality and guideline compliance.

• Conduct 1:1 meetings and drive weekly prioritization discussions

• Performs performance reviews, merit, and ICP activities. Conducts team meetings to update members on standard processes and continuing expectations.

• The candidate will follow SOPs and work in compliance with EH&S, GLP, and any other required manufacturing or company systems (e.g., E1, Agile, Trackwise, etc.).

• This position will be responsible for supporting the team in achieving daily production schedules and product quality goals.

• Mammalian cell Culture and cells using an aseptic technique.

• Operate manual and automated laboratory equipment like HPLC, Mass Spec, ELISA, PCR, etc.

• Record information accurately into various electronic databases (e.g., raw and calculated data, inventory transfers, routing hours).

• Review data, recognize and report inconsistencies to the .supervisor

• Troubleshoot and think critically. Anticipate needs and problems while crafting solutions using the PPI (Practical Process Improvement) tool

• Scheduling, closing work orders, and NPI. Understand and apply good documentation practices consistently when documenting work. Follows ThermoFisher Scientific safety guidelines

• On-call Hours required

Education/Job Requirements

• Bachelor's degree (Required) in Biology or related field

• Experience with E1, Agile, Trackwise, Documentum as well as MS Office

• 1-2 Years of leadership experience

• 4+ years’ experience working with HPLC, Mass Spec, ELISA, PCR, Cell culture, primary cells, stem cells, GDP/cGMP, Etc,

Knowledge, Skills, and Abilities

• Reliable

• Quick learner

• Sets an example by demonstrating excellence

• Detail oriented

• Self-motivated

• Highly organized

• Focused

• Great Teammate

• Required to be on call monthly

Excellent Benefits!

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off (120 hours per year) & 10 Paid Holidays

• 401K Plan - When you contribute, the company matches 100% of those dollars, up to 6% of your eligible pay

• Tuition Reimbursement – eligible after 90 days!

• Employee Referral Bonus

• Career Advancement Opportunities

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.