Quality Assurance Quality Control

7 days ago


Branchburg Township, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • 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.

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

  • This role performs visual inspection for incoming 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.

  • Shift: Tuesday-Saturday 7:30am-4pm

Qualification

  • Adaptability

  • Attention to detail.

  • Critical Thinking and Problem solving

  • Communication

  • Decision Making

  • Proficient in all areas of QC Tissue Receipt.

  • 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.

  • 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 biohazardess materials, including cadaveric tissue.

  • Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time.

  • Ability to carryout 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.



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