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Synectics Inc. · 5 days ago

Quality Assurance Quality Control (QA-QC) Inspector

Branchburg, NJ

Contract

Onsite

Mid, Senior Level

5+ years exp

Synectics Inc. is seeking a Quality Assurance Quality Control (QA-QC) Inspector. This role involves inspecting and receiving human and porcine tissue, ensuring compliance with procedures and regulations, and supporting departmental needs through various quality control activities.

ConsultingInformation TechnologyRecruitingStaffing Agency

Responsibilities

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

Qualification

CGMPsISOFDASAP (ERP)Lean Six SigmaAdvanced Computer SkillsAttention to detailCritical ThinkingBasic statistical techniquesCommunicationDecision MakingAdaptability

Required

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 biohazardous materials, including cadaveric tissue

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

Preferred

5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry preferred

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.