Team Leader, QC
Team Leader, QC
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowedJob Description
When your part of the team youll do important work like helping customers with finding cures for cancer protecting the environment or making sure our food is safe. Your work will have realworld impact and youll be supported in achieving your career goals. As a Manufacturing Quality Leader youll help ensure quality products are delivered to our customers safely and on time. You will partner with the production team to tackle problems improve processes and ensure that our quality management system (QMS) continues to mature with changing customer and regulatory expectations!
How will you make an impact
Leading the Quality Control Technicians inspecting final productSingle Use Systems to be used by our customers to manufacture lifesaving drugs or biotherapies. These final products will be used by the highly regulated biopharmaceutical industry and must be delivered on time with the highest quality. Your oversight of the QC team who conducts the inprocess and final inspection of these crucial products is a critical component of the sites QMS and the overall integrity of the final product. Furthermore it is a crucial element to the sites ability to deliver products on time efficiently and profitably.
Position Summary:
Support advancement of proactive quality initiatives and projects such as Design for Manufacturability QC Optimization and Defects Review Board. Act as a delegate to
Supervise and develop QCTS. This positionis in a 24hr production facility and may have responsibilities across multiple shifts. This position requires a successful candidate to Supervise Train Mentor Identify and Solve problemsand support QC team management.
Responsibilities:
Assign QCTs to various Value Streams as the need arises and according to production/inspection demand.
Perform trending of inprocess QC data
Support advancement of proactive quality initiatives and projects such as Design for Manufacturability QC Optimization and Defects Review Board
Problem Solving support customer complaints / atypical event management
Document Management draft edit review standard operating procedures (SOPs) and testing protocols
Testing establish optimize andexecute test methods and test protocols
Continuous Improvement apply practical process improvement (PPI) methodology to improve in the areas of quality safety and efficiency
New Product and Process development work closely with engineering to implement new products and processes
Auditing to site QMS ISO 13485 and FDA 21 CFR 820 standards
Required Qualifications:
2year associate degree
2 year(s) experience in supervising others
Excellent writing and interpersonal skills
Ability to interface well with all other working levels
Preferred Qualifications:
Experience in Manufacturing Environment
Technical Writing Experience
Working knowledge of Root Cause Countermeasures process
Knowledge of ISO13485
Knowledge of FDA 21CFR820
Ability to read and understand CAD drawings
Understanding of Metrology
Experience with cGMP manufacturing
Lean Six Sigma Understanding
Bachelors degree from an accredited higher learning program with majors in science or businessrelated field.
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Employment Type
Full-Time
