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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters 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 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
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Director, Quality Control
The Quality Control Director is responsible for the oversight of all Quality Control Laboratory functions, activities, and personnel at the Axogen Processing Center (APC) and associated contract laboratories. This includes all analyses done on donor tissue, raw materials, and in process, product release, environmental monitoring, and commercial product stability samples. Additionally, the Quality Control Director builds and maintains collaborative work relationships with APC and company Operations, Quality Assurance, Finance, and Regulatory leaders to drive cross-functional planning and decision-making regarding Quality Control Laboratory operations and process improvement.
Requirements of the Director, Quality Control
- Bachelor's degree in chemistry, biology or other sciences related field.
- Minimum of ten (10) years of relevant industry experience.
- Minimum of six (6) years QC supervisory experience (hiring and coaching associates and supervisors).
- 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 processing environment.
- Experience working in an FDA or AATB regulated industry.
- Strong skills in communicating technical and scientific information.
- Strong organizational and problem-solving skills.
Responsibilities of the Director, Quality Control
The specific duties of the Director, Quality Control include but are not limited to:
- Leads the APC Quality Control Laboratory, including organizational design, operating budget, personnel recruiting, and employee technical and behavioral competency development and training.
- Collaborates across the company representing the Quality Control Laboratory, engaging with stakeholders and business partners in both a technical and management leadership capacity.
- Ensures the Quality Control support strategy for the APC site is technically sound and in alignment with business objectives and quality/regulatory requirements. Owns key laboratory QMS processes, including deviations, CAPA actions, implementing compendia changes, technical problem solving, and monitoring operational results via trend analyses.
- Creates an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspires Quality Control team members to achieve short and long-term goals.
- Sets an expectation of achieving outcomes, continuous learning, and shared accountability; champions a mindset of inclusivity, speaking up, and coaching others.
- Takes proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies.
- Embodies Lean principles and methodologies and promotes a continuous improvement culture throughout the Quality Control organization by encouraging experimentation and learning.
- Provides laboratory oversite regarding Out of Specification results and associated investigations, both with internal and external contract testing laboratories.
- Represents the Quality Control Lab during regulatory inspections and internal audits.
- Performs all other duties as assigned.
Location
913 Industrial Drive Place, Vandalia, OH 45377
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Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 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, and Disability Insurance, as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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