Quality Assurance Quality Control (QA-QC) Inspector

Position Title:

Quality Assurance Quality Control (QA-QC)

Inspector Work Location:

Branchburg, NJ 08876

Assignment Duration:

6

Months Work Schedule:

Tuesday - Saturday from 8:00 AM to 4:30

PM Work Arrangement:

Onsite Position Summary:

Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities. Ensures quarantine, receiving, cycle count, cleaning, media change and review activities are performed in accordance with all applicable procedures, regulations, and established specification requirements.

Background & Context:

This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks. Provide technical support to teams and cross-functional teams to ensure effective operations. Proficient in all areas of QC Tissue Receipt.

Key Responsibilities:

• Supports and partners with cross-functional teams to resolve any issues or nonconformance encountered.
• Assists in documentation updates and related change controls activities as needed.
• Perform applicable actions for Exception Reports (ERs), CAPAs, Supplier Related ERs, LIR's, Change Controls (ECOs), etc.
• This role is also responsible for identifying, coordinating, and implementing 5S and Lean Six Sigma continuous improvements initiatives.

Qualification & Experience:

• Ability to carry and lift boxes weighing up to 50 lbs.
• Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time.
• Ability to work with human and porcine raw materials and finished goods in specifically defined functional areas.
• Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.
• Ability to carryout detailed written or oral instructions.
• Ability to handle a wide variety of tasks under critical time constraints.
• Must be comfortable working in a lab, warehouse and manufacturing settings.
• Willing to work with potentially biohazardess materials, including cadaveric tissue.
• Computer proficiency and scheduling experience required; good writing skills required.
• Bachelor's degree preferred.
• AATB certification preferred.
• 5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry preferred.

Working Conditions & Physical Demands:

• Ability to carry and lift boxes weighing up to 50 lbs.
• Ability to walk, lift, bend, squat, stoop, stretch, sit, and stand for long periods.
• Ability to work with human and porcine raw materials and finished goods in specifically defined functional areas.
• Flexibility to work a varied schedule with potential weekend, early morning, or late evening hours, if needed.