Quality Engineer III

Job Title: Quality Engineer III
Location: Greenville, NC 27834
Duration: 9months W2 contract with high possibility of extension based on performance and depending on business needs
Shift Timing: 6 PM–6 AM, 2-2-3 rotation is a common 12-hour shift schedule
Description:
In this position, you ll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6p – 6a, on a 2-2-3 rotation.
Key Responsibilities:
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
Champions quality culture by aiding personnel in understanding application of policies and controls
Participates in RAPID event response and provides quality guidance for deviation events
Advances deviation events to the appropriate area and quality management
Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
Performs quality review and approval of deviation and change control of moderate to high complexity
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
Performs quality batch record review
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
Qualifications:
Bachelor s degree, preferably in technology, engineering or microbiology related field required.
Equivalent combinations of education, training, and relevant work experience may be considered
A minimum of 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
Ability to capture data, analyze & troubleshooting process issues, equipment problems along with production leadership
Ability to troubleshoot process and equipment issues
Hard-working, demonstrated ownership & responsibility.
Ability to lead, support & empower a team/peers
Technical Writing experience
Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.