Quality Analyst (2nd Shift)

Axogen • Vandalia, OH

407d

About The Position

The Quality Analyst I is responsible for performing quality control inspections and managing non-conforming materials and products in accordance with Axogen's Quality System. This role involves using measuring instruments and inspection methods to ensure compliance with FDA, OSHA, and ISO regulations. The Quality Analyst will work under limited supervision and is expected to follow all company policies and procedures.

Requirements

• 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

• Perform reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinate and track CAPA, NCR, and Deviation records, ensuring tasks are completed on time.
• Coordinate and track the site environmental monitoring (EM) testing program.
• Assist teams in coordination of problem-solving and root cause analysis for associated quality events.
• Ensure the development, review, and release of quarterly EM trending reports; ensure significant trends are immediately brought to management's attention.
• Provide input based on knowledge and experience with batch release requirements.
• Provide QMS Operations related support to all CGMP departments.
• Perform Quality Control activities at AxoGen's processing or distribution sites.
• Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provide support related to gowning qualification and training.
• Ensure timely issuance, review, and approval of Microbiology and EM testing results.
• Interface with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Assist in the review and approval of equipment qualifications.
• Assist in the review of Calibration and Preventative Maintenance reviews.
• Assist in hosting onsite regulatory audits and inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree