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
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: https://www.axogeninc.com/patient-stories/
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 Quality Analyst
The Quality Analyst I performs quality control (QC) inspection and disposition of materials and products according to specifications. This role will perform QC inspection using measuring instruments (when applicable) and inspection methods. The role ensures any non-conforming materials or products that are identified are managed according to Axogen's Quality System. The Quality Analyst is responsible for following all Axogen policies and procedures to ensure compliance with applicable FDA, state OSHA, and ISO regs and standards. Employees within this role will perform a variety of tasks under limited supervision.
Requirements of the Quality Analyst
Bachelor's Degree in a Life Science discipline and/or in a related field.
Bachelor's degree in engineering preferred.
Minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization.
Familiarity with ANSI/ASQ Z1.4-2003, c=0, and AQL methodologies preferred
Experience in an FDA-regulated environment, particularly medical device, human tissue, or pharmaceutical manufacturing preferred.
Experience with Microsoft Excel
Experience writing Standard Operating Procedures and Work Instructions
Experience with Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations.
Responsibilities of the Quality Analyst
The specific duties of the Quality Analyst include but are not limited to:
Performs reviews of batch production records and manufacturing records as part of lot release activities.
Coordinates and tracks CAPA, NCR, and Deviation records, ensuring tasks are completed on time.
Coordinates and tracks the site environmental monitoring (EM) testing program.
Assists teams in coordination of problem-solving and root cause analysis for associated quality events.
Ensures the development, review, and release of quarterly EM trending reports; Ensures significant trends are immediately brought to management's attention.
Provides input based on knowledge and experience with batch release requirements.
Provides QMS Operations related support to all CGMP departments.
Performs Quality Control activities at AxoGen's processing or distribution sites. The Quality Analyst will be responsible for incoming material inspections, in-process inspections, and finished product inspections.
Products include Medical Devices, sterile processed Human Tissue-Based Products, unprocessed human tissue, components supplies, and labeling materials.
The Quality Analyst will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
Provides support related to gowning qualification and training.
Ensures timely issuance, review, and approval of Microbiology and EM testing results.
Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
Assists in the review and approval of equipment qualifications.
Assists in the review of Calibration and Preventative Maintenance reviews.
Assists in hosting onsite regulatory audits and inspections.
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.
Salary Range
$55,075-$68,843 USD
Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.
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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