Quality Control Inspector in Branchburg, NJ

100% on site

Work schedule Tuesday-Saturday 7:30 AM-4 PM

Duties:

• 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.
• 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.
• This role is also responsible for identifying, coordinating, and implementing 5S and Lean Six Sigma continuous improvements initiatives.
• 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.

What are the top 3-5 skills, experience or education required for this position:

Professional Skills:

• Adaptability
• Attention to detail.
• Critical Thinking and Problem solving
• Communication
• Decision Making

Other Professional Skills:

• 5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry preferred.
• Advanced Computer Skills-High knowledge and understanding of Windows based computer systems.
• cGMPs, AATB Standards, ISO, FDA and USP regulatory guidelines
• SAP (ERP)
• Basic knowledge of statistical techniques and quality tools.

Job Qualification minimum requirements:

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

Additional Information:

• To provide some additional information related to the role, we do not perform environmental/histological/microbial testing.
• This role performs visual inspection for incoming human cadaver tissue and performs a subsequent review to ensure specification requirements are acceptable for further processing.
• This role also performs data entries on paper batch records as well as SAP (ERP), Quarantine activities related to NCR’s (ER), cycle count, inventory management, Cross-functional communication across multiple departments etc.

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