Quality Analyst - 3rd shift
Summary
Quality Analyst on 3rd shift performing QC inspections, batch record reviews, and QMS operations (CAPA, NCR, deviations) for medical device and human tissue-based products at Axogen's Vandalia, OH facility.
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
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.
- 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
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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.
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.
Skills
As published by greenhouse · 16 questions · 3 written answers
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (4)
- Please provide your current zip code.
- What is the highest level of education you have completed and area of focus?
- Are you local to Vandalia, OH or relocating to the area?
- How many years of relevant industry QA experience do you have within a Medical Device, Pharmaceutical, or Tissue commercial organization?
Pick from a list (9)
- Are you over the age of 18 years old?
- Are you able to perform the essential functions of this position, with or without reasonable accommodation?
- Are you able to provide proof of your right to work in the US if hired?
- Do you now, or in the future, will you require sponsorship by Axogen to work in the US?
- Have you previously worked for Axogen?
- Do you have an active non-compete or similar agreement that might prevent you from being permitted to work with Axogen? If yes, please email a copy to: talentacquisitioninterviews@axogeninc.com.
- Do you have experience in an FDA-regulated environment?
- Are you able to work 3rd shift (11pm - 730am, Sunday night - Friday morning)?
- APPLICATION ACKNOWLEDGMENT I acknowledge that I have read this Application for Employment. I acknowledge that I understood each and every question that was asked of me in the Application for Employment. I acknowledge that I was given the opportunity by Axogen to ask questions regarding the Application for Employment and the hiring process. I acknowledge that if Axogen employs me, I will be free to leave Axogen at any time for any reason and that Axogen is free to separate my employment at any time and for any reason without prior notice. I understand that this is called “employment at will,” and no one other than an officer of Axogen has the authority to alter this arrangement, to enter into an agreement for employment for a specified period of time, and/or to make any agreement contrary to the at-will nature of my employment. Furthermore, I understand that any such agreement that is contrary to the at-will nature of my employment must be in writing signed by an officer of Axogen. I acknowledge and understand that by submitting this application, Axogen may use some of the information stated in this application and my resume if provided to: conduct necessary background or credit checks, contact references and prior employers, verify licenses, or obtain any other relevant information deemed necessary. Further, if I am offered a position by Axogen, the job offer is contingent on the satisfactory completion of: a background check, a drug test, any job-related medical evaluation, any job-related quality training, proof of my legal identification, and authorization to work in the United States, and verification of any of the information that I provided. I acknowledge and affirm that the answers I have provided in this application and resume (if provided) for employment are true and accurate. I further acknowledge that I have not withheld any information that was requested of me in this application for employment. I understand and acknowledge that any misrepresentations, false statements, and/or omissions made by me in completing this application for employment may result in me not being considered for employment by Axogen and/or may lead to disciplinary action, up to and including the separation of my employment if discovered by Axogen after I have been hired. Therefore, I agree that if I am hired by Axogen, and I unknowingly wrote or later learn that something false or inaccurate is on this application, I am required to correct any and all inaccurate statements.
Written answers (3)
- Do you have any relatives or household members working at Axogen or an Axogen partner currently? If yes, who?
- What are your compensation expectations (please list salary or hourly rate and bonus/commission separately)?
- If you accept an offer of employment from us, we will need your legal name as it appears on your social security card or other legal documents. Please provide your legal name below, including any suffixes (ex. Jr., Sr., III)