About the position
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 perform a variety of tasks under limited supervision.
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; ensures 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.
- 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.
Requirements
- 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.
- 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.
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 insurance.
- Paid Time Off.
- Dependent Care Flexible Spending Accounts.
- Medical Flexible Spending Accounts.
- Tuition Reimbursement.
- Paid Parental Leave.
- Paid Caregiver Leave.
- Basic Life Insurance.
- Supplemental Life Insurance.
- Disability Insurance.
