axogen · 2 days ago
Quality Analyst - 2nd Shift
Vandalia, Ohio, United States
Full-time
Onsite
New Grad, Entry Level
$57K/yr - $71K/yr
0+ years expAxogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. The Quality Analyst performs quality control inspections and ensures compliance with applicable regulations while managing non-conforming materials or products.
BiotechnologyMedicalMedical Device
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 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; assures significant trends are immediately brought to management 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
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
Maintains 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 of onsite regulatory audits and inspections
Qualification
Required
Able to work 3:00 pm - 11:30 pm, Monday - Friday
High School Diploma and minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization
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
Preferred
Bachelor's Degree in a Life Science discipline, engineering, or in a related field preferred
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
Benefits
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
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
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$131.92MKey Investors
PDL Biopharma
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
2015-02-05Post Ipo Equity· $13M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
2026-01-13
GlobeNewswire
2026-01-12
2025-12-05
Company data provided by crunchbase