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Description

Quality Assurance On-Line Tier I

Corporate Statement

Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability.

Position Summary:

* Performs Weight Check and Quality Attributes Inspection of the product through the packaging process in compliance with company policies / procedures, FDA and cGMP regulations.

* Ensures the accuracy and completeness of lot records

* Performs other duties as assigned or apparent.

NOTE: The primary accountabilities 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.

Primary Accountabilities:

* Successfully complete QA OJT packet.

* Successfully complete LBR (General Use), training.

* Successfully complete DEA certification.

* Review production lot records for GDP accuracy.

* Monitor and perform start up, in-process and finished product inspections including weighing, attribute inspections during production.

* Maintain quality assurance documentation.

* Promote teamwork both within the QA area and other departments.

* Monitor all production areas and personnel for adherence to all GMP, SOP's and safety regulations.

* Keep line and work station clean and orderly.

* Verify incoming packaging materials, raw material chemicals, in process and finished products.

* Ensure no product line contamination.

* Perform line clearances including equipment, components and label verification.

* Inspect and release machines and processing rooms for production.

* Support validation and manufacturing studies including special sampling and testing.

* Organize workload during lot changeovers for efficient execution.

* Review and approve production lot records for release into production.

* Release finished product for packaging.

* Investigate out of range percentages.

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

* Review all completed production lot record documentation to ensure completeness and compliance.

Requirements

Knowledge, Skills & Abilities

* High School Diploma or GED.

* Minimum of 1 year of pharmaceutical/medical device Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred.

* Detail oriented.

* Good computer skills in MS Outlook, MS Word, MS Excel, internet, email and basic typing skills.

* Good visual acuity and observation skills

* Good written, oral and comprehensive communication skills

* Able to handle diversity of projects.

* Specific expertise, skills and knowledge within quality assurance gained through education and experience.

* A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.

* The ability and willingness to change direction and focus to meet shifting organizational and business demands

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

EEO Statement:

Nephron Nitrile is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Nitrile is a drug free workplace.