Quality Analyst - Medical Devices (3rd Shift, Bonus)

axogen; Vandalia (OH); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Shift differential pay (2nd/3rd shift)

Annual bonus

Health insurance

Dental

Vision

Matching 401K

Paid time off

Holidays + floating holidays

Dependent Care FSA

Medical benefits

Job summary

Axogen is seeking a Quality Analyst to perform QC inspections and dispositions of materials and products according to specifications. This role ensures non-conforming materials or products are managed under Axogen's Quality System, following FDA, state OSHA and ISO regs and standards.

The Quality Analyst is responsible for following all Axogen policies and procedures to ensure compliance with applicable FDA, state OSHA and ISO regs and standards.

Qualifications

• 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

• 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.

Skills

Quality Assurance

FDA compliance

Root cause analysis

Documentation

CAPA management

SOP writing

Work Instructions

Education

Bachelor's Degree in Life Science or related field

Tools

Microsoft Excel

Job description

Axogen is seeking a Quality Analyst to perform QC inspections and dispositions of materials and products according to specifications. This role ensures non-conforming materials or products are managed under Axogen's Quality System, following FDA, state OSHA and ISO regs and standards.

The Quality Analyst is responsible for following all Axogen policies and procedures to ensure compliance with applicable FDA, state OSHA and ISO regs and standards.