Quality Analyst (2nd Shift) - Remote

Overview

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.

In Short

• Perform quality control inspections and disposition of materials and products.
• Ensure compliance with FDA, state OSHA, and ISO regulations.
• Coordinate and track CAPA, NCR, and Deviation records.
• Assist in problem-solving and root cause analysis for quality events.
• Maintain accurate records of Quality Control activities.
• Perform reviews of batch production and manufacturing records.
• Provide support related to gowning qualification and training.
• Assist in hosting onsite regulatory audits and inspections.
• Experience in an FDA-regulated environment preferred.
• Flexible working hours available.

Requirements

• Bachelor’s Degree in a Life Science discipline or related field.
• 0-2 years of relevant industry experience.
• Familiarity with ANSI/ASQ Z1.4-2003, c=0, and AQL methodologies preferred.
• Experience with Microsoft Excel.
• Experience writing Standard Operating Procedures.
• Experience with Quality System elements for CAPA and NCRs.
• Ability to perform QC inspections using measuring instruments.
• Strong attention to detail and documentation practices.
• Ability to work under limited supervision.
• Experience in medical device or pharmaceutical manufacturing preferred.

Benefits

• Comprehensive benefits package effective on date of hire.
• Educational assistance available for all employees.
• Matching 401(k) retirement plan.
• Paid holidays, including floating holidays.
• Employee Stock Purchase Plan.
• Referral incentive program.
• Health, Dental, and Vision insurance.
• Paid Time Off and Paid Parental Leave.
• Disability Insurance and Life Insurance options.
• Tuition Reimbursement available.