Description

Position Summary:

· Be responsible for quality of the products in assigned area

· Coordinates Quality Inspectors in shift to ensure timely completion to planned activities and sampling plans

· Ensure Quality Inspectors in shift are trained and adhere to approved procedures

· Be responsible for completion of daily paperwork and daily recordings of team data

· Partner with Production Supervisor to proper support to production activities

· Assist with conflict resolution and performance of Quality Inspectors

· Send reports to management and peers to inform shift incidents, trends and follow-up actions

Primary Responsibilities: 

· Assists Quality Assurance Leader or designee with product release for Nephron Nitrile, including any outstanding laboratory testing and any other quality responsibilities required by Quality Operations

· Coordinate with Quality Management to communicate priorities to Quality operations

· Clarify finished product acceptance criteria and release specifications 

· Communicate quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to QA Management or designee

· Assist Quality Management with initiatives, campaigns, and special projects.

· Review production lot records for GPD accuracy

· Promote teamwork both within QA area and other departments

· Organize workload during lot changeovers for efficient execution

Report any issues to Production and Quality command chain. 

Requirements

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and knowledge, skills and abilities listed below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

· High School Diploma or GED preferred,

· 1-3 years of experience in quality inspection in manufacturing environments of highly regulated industry (e.g. medical device, food, automotive or pharmaceutical)

· At least 1 year of prior experience leading teams is highly preferred

· 2-4 years of experience with MS Word, Excel, and PowerPoint preferred

· Experience in assisting the monitoring of all quality areas and personnel for adherence to all cGMP, SOP’s, and safety regulations for purposes of product release

· Good written and oral communication skills, including technical writing

· Effective decision making based on approved procedures and specifications

· Team Player, must be able to interact within all departments of the company

· Ability to work independently, and dependable

· Ability to accept accountability to drive results through effective actions

· The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition

· The ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve development goals

· Position requires lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing, and hearing

· When appropriate incumbents will wear specified protective equipment

· Strong attention to detail

· Good visual acuity and observation skills

· Must be able to stand for long periods

· Must be able to work 12hr shifts. This is a 24/7 operation and will require weekends and/or holidays to be staffed.

Salary range: Based on experience.