Quality Specialist III, Quality on the Floor (12-hour Nights)

at  Thermo Fisher Scientific

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

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.

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 & troubleshoot 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.

• 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
• Champion quality culture by aiding personnel in understanding application of policies and controls
• Participate in RAPID event response and provides quality guidance for deviation events
• Advance deviation events to the appropriate area and quality management
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity
• Perform quality review and approval of deviation and change control of moderate to high complexity
• Participate as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
• Perform quality batch record review
• Aid in identification of continuous improvement opportunities; Participate in practical process improvement initiatives