Quality specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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.

 

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
• Participate in RAPID event response and provides quality guidance for deviation events
• Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
• Performs quality batch record review
• Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
• Support client quality interactions and regulatory inspections.
• Develop and maintain BRR SOPs and training materials.
• Partner with operations to improve documentation accuracy and compliance

Qualifications:

• Bachelor's degree required, preferably in a scientific related field.
• A minimum of 5 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
• Equivalent combinations of education, training, and relevant work experience may be considered
• Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
• Hard-working, demonstrated ownership & responsibility;
• Ability to lead, support & empower a team/peers
• Professional certifications (ex: CQA) and training (Six Sigma) are a plus 

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.