Quality Assurance Quality Control (QA-QC) Inspector II
1 Millennium Way Somerville, NJ 08876 US
Job Description
JOB SUMMARY:
This role performs porcine and human tissue receipt and inspection, E-Beam In (WIP product) receipt and inspection, and tissue discard as per procedures. Requires extensive use of an enterprise resource planning (ERP) system. Demonstrates a Quality mindset when engaging in all work activities and ensures safety requirements are met. Supports and partners with cross-functional teams to resolve any issues or non-conformities encountered. Assists in documentation updates and related change controls activities as needed. Performs applicable actions for Exception Reports (ERs), Document Change Controls (DCCs), etc.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- Ability to lift boxes weighing up to 50 lbs.
- Ability to work varied schedule with some potential weekend, early morning, or late evening hours, if needed.
- Must be comfortable working in warehouse and manufacturing settings.
- Must be willing to work with potentially biohazardous materials, including cadaveric tissue
- Ability to walk, lift, bend, climb, squat, stoop, stretch, stand, and sit for long periods of time.
- Must be willing to work with potentially biohazardous materials.
- AATB certification preferred.
- Ability to carry out detailed written or oral instructions
- Ability to handle a wide variety of tasks under critical time constraints
Education and Experience
- High School required. Associate or bachelors degree preferred.
- 2 - 4 years of experience in a GMP environment performing Quality Inspection related duties as listed in Key Duties & Responsibilities or related activities.
- Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, ISO, FDA, and/or USP requirements.
- Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.
ESSENTIAL SKILLS:
- Advanced skills in Windows based computer systems such as Microsoft Office Suite.
- Demonstrated knowledge of Quality Control inspection techniques.
- Strong organizational abilities and problem-solving skills
- Detail-oriented and self-motivated
- Strong interpersonal skills
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