Quality Control Manager

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Job description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

* Friendly, open, and fun team culture that values unique perspectives
* Company-wide dedication to profoundly impacting patients' lives
* Comprehensive, high-quality benefits package effective on date of hire
* Educational assistance available for all employees
* Matching 401(k) retirement plan
* Flexible working hours
* Paid holidays, including floating holidays, to be used at your discretion
* Employee Stock Purchase Plan
* Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories:

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, and the commercial stability program.

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

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

Responsibilities of the Quality Control Manager

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

* Be the primary point of contact for the build, commissioning, and qualification of the new QC laboratories at the Axogen Processing Center.
* Coordinates management and staffing of Microbiology, Histology, and Incoming Raw Material Quality Control teams and operations.
* Builds a robust incoming material receipt and inspection process consistent with 21 CFR 211 requirements.
* Provides technical oversight for tech transfer to and from Axogen to external contract testing laboratories.
* 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.
* Collaborate with supply chain operations and R&D partners, including external suppliers and contract testing laboratories to assure quality of product.
* Collaborates with 3rd party laboratories on the analytical testing of all products to demonstrate compliance with specifications.
* Tracks Out of Specification results and associated investigations, both with internal and external contract testing laboratories.
* Oversees external Contract Testing Laboratory compliance to regulatory requirements.
* Participates in regulatory inspections and internal inspections.
* Performs all other duties as assigned.

If you know someone who would be a great candidate for this position, just copy and send this link!

Location

913 Industrial Drive Place Vandalia, OH 45377

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