Manager, Quality Control Jobs

Axogen is hiring for a Quality Control Manager in Vandalia, OH!

Job Summary of the Quality Control Manager

The Quality Control Manager is responsible for the oversight of all laboratory functions, activities, and personnel at the Axogen Processing Center and associated contract laboratories. Responsible for all testing done on donor tissue, raw material testing, in process sample testing, release testing, and utility and environmental monitoring testing. Also responsible for the commercial stability and retention program management for Axogen. Additionally, the Quality Control Manager will work with Operations, Supplier Quality, and R&D teams to provide laboratory support.

Requirements of the Quality Control Manager

• Experience working in sterile environment.
• Strong organizational and problem-solving skills
• Strong laboratory skills (microbiology, histology, and incoming quality control).
• Strong skills in communicating technical and scientific information.
• Minimum of (10) years of relevant industry experience.
• Experience in the validation and transfer of analytical methods from/to R&D and/or contract laboratories.
• Bachelor's degree in chemistry, biology or other sciences related field.
• Experience working in FDA or AATB regulated industry.
• Minimum of (5) years supervisory experience hiring and coaching.

Responsibilities of the Quality Control Manager

The specific duties of the Quality Control Manager include but are not limited to:

• Provides technical quality support and QC feasibility to the research and development teams related to test method development, validation, and transfer.
• Lead quality issue resolution for out-of-specification results and quality issues identified in R&D and Commercial areas related to product and process both from internal and external laboratories.
• Manages the operations, training, development, and staffing of Microbiology, Histology, and Incoming Raw Material Quality Control teams to support three shift, five day processing operations.
• Uses lean six sigma tools to build metrics and drive performance in safety, quality, production, and morale.
• Collaborate with supply chain operations and R&D partners, including external suppliers and contract testing laboratories to assure quality of product.
• Be the primary point of contact for the qualification of the new QC laboratories at the Axogen Processing Center. Project manage any subsequent expansion projects.
• Provides technical oversight for tech transfer to and from external contract testing laboratories.
• Collaborates with 3rd party laboratories on the analytical testing of all products to demonstrate compliance with specifications.
• Participates in regulatory inspections and internal inspections.
• Performs all other duties as assigned.
• Tracks Out of Specification results and associated investigations, both with internal and external contract testing laboratories.
• Builds and manages an incoming material receipt and inspection process consistent with 21 CFR 211 requirements.

Location

913 Industrial Drive Place, Vandalia, OH 45377

Compensation

The anticipated base wage or salary range for this position is $104,236 - $130,295.

The anticipated range for target compensation in the form of an annual bonus of 15% of base.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, Equity, and Disability insurance, as described in more detail in summary plan descriptions.

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