Quality Analyst - 3rd shift

Axogen, Inc.; Vandalia (OH); On-site; USD 57,000 - 71,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Matching 401K

Paid time off

9 holidays + 3 floating holidays

Employee stock purchase plan

Tuition reimbursement

Paid parental leave

Disability insurance

Job summary

Axogen is seeking a Quality Analyst to perform QC inspections and dispositions of materials and products per specifications at Vandalia, OH. The role ensures non-conforming items are handled per the Quality System and FDA/ISO standards.

The incumbent will conduct batch-record reviews, track CAPA/NCR/Deviations, and support CGMP operations. Requires a Life Sciences or related field degree and 0–2 years in a regulated environment. 3rd shift is possible.

Qualifications

• Bachelor's degree in life sciences, engineering or related field preferred.
• 0–2 years of relevant industry experience in medical device/pharma is acceptable.

Responsibilities

• Performs reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinates and tracks CAPA, NCR and Deviation records, ensuring timely completion.
• Picks, maintains, and regulates custody of biologic finished goods.
• Assists teams in problem solving and root cause analysis for quality events.
• Provides input on batch release requirements.

Skills

Quality control

Root cause analysis

US FDA regulations

Excel

Education

Bachelor's degree in Life Sciences or engineering

High School Diploma

Tools

Microsoft Excel

Job description

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 Quality Analyst

The Quality Analyst performs quality control (QC) inspections and dispositions 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 with FDA, state OSHA and ISO regs and standards. Employees within this role will performs a variety of tasks under limited supervision.

Requirements of the Quality Analyst

• Bachelor's Degree in a Life Science discipline, engineering, or in a related field preferred.
• High School Diploma and minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization.
• Able to work 3rd shift (11pm - 730am, Sunday night - Friday morning).
• 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

• 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.
• Picks, maintains, and regulates the custody and movement of biologic finished goods.
• Assists teams in coordination of problem solving and root cause analysis for associated quality events.
• 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.
• 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 hosing of onsite regulatory audits and inspections.

Location

913 Industrial Drive Place, Vandalia, OH 45377

Benefits/Compensation

• 2nd and 3rd shift Quality Analysts are eligible for shift differential pay.
• 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

$56,730 - $70,900 USD

Company Statements

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. As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen. No agency solicitation. We kindly request that recruiting agencies, staffing firms, and third-party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.