Quality Inspector 2

Evergen•West Lafayette, IN

4d•Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

Requirements

High school diploma or GED required.
Associate of Science degree or Quality Assurance experience in a medical device, pharmaceutical or biological field or equivalent job experience is preferred.
2 to 4 years of relevant experience.
Working knowledge of 21 CFR 820, ISO 9001 and ISO 13485.
Able to work with multiple persons and varying priorities.
Able to handle multiple and changing priorities along with fluctuations in workload.
Strong attention to detail.
Understands the computer database system.
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Responsibilities

Review and approve batch record documentation prior to use on product floor.
Review batch supporting documentation.
Data entry to add material into the “system”.
Move material from quarantine to production refrigerator.
Coordinate the performance of investigations and corrections for incomplete/unexplained issues found during the batch record review process.
Track and ensure completion of corrective actions resulting from batch record issues.
Perform data entry duties in various computer databases.
Perform incoming quality inspections and testing according to written instruction.
Perform final inspection of products before release to Post-Sterilization Services.
Identify and segregate any non-conforming product as determined by instructions and/or specifications.
Generate and maintain records related to product testing.
Assist in keeping work areas clean and orderly.
Report deviations and other potential problems to Supervisor is a timely manner.
Review work orders prior to releasing products from EO and Ebeam.
Receive and complete sterile run documentation on a timely basis.
Apply understanding of the Quality System Requirements in executing job duties.
Conduct other corporate duties when required.
Decision Making- Uses skills and experience to make recommendations. Continued supervisor/peer oversight.
Team dynamics- Works well with local team and members outside of local team
Change/Innovation- Proposes ideas and implements incremental improvements.
Level of responsibility (project based)- Multiple sequential tasks.
Knowledge (business) Understands main business processes and functions for local area of responsibility.
Level of responsibility (function) Specific function within an area
Knowledge (technical)- Performs basic technical tasks and works to acquire new skills.
Assist in QA lab as necessary.