Quality Specialist III

Thermo Fisher Scientific•Greenville, NC

23d

About The Position

The Quality Specialist III provides Quality oversight in the steriles lab for processes and projects, performs compliance assessments, makes decisions regarding regulatory requirements, writes new procedures, and ensures adherence to current regulations. The role supports Thermo Fisher Scientific’s mission to enable customers to make the world healthier, cleaner, and safer. The position involves daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas, as well as support and guidance for employees on troubleshooting, documentation, and aseptic technique. The Quality Specialist III contributes to deviation response and investigation, reviews and approves quality documents and change controls, reviews batch records and/or supports batch disposition, and participates in continuous improvement initiatives. The position follows a standard Monday–Friday schedule in a laboratory and office setting. Work requires adherence to GMP safety standards and use of some personal protective equipment. Extended hours may be needed, especially during health authority inspections, assessments, and audits.

Requirements

Bachelor’s degree in a scientific or related field.
At least 5 years of cGMP experience in the pharmaceutical industry.
At least 2 years in one or more of Quality Engineering, Compliance, or Regulatory Affairs.
Previous experience in a cGMP environment.
Ability to maintain focus and prioritize in a fast-paced, evolving environment.
Excellent interpersonal skills and the tact to handle critical matters while maintaining effective working relationships with employees and the public.
Demonstrated problem-solving and decision-making ability.
Strong organizational, presentation, meeting facilitation, and technical writing skills.
Excellent verbal and written communication skills.
Outstanding attention to detail and ability to work in a fast-paced environment.
Ability to function independently and as part of a team, with strong interpersonal skills.
Strong computer proficiency, including MS Office, TrackWise, and SAP or equivalent systems.
Ability to work extended hours, especially during health authority inspections, assessments, and audits.
Ability to move about office locations; periodically stand, walk, stoop, kneel, and crouch for prolonged periods; handle light to medium weights of 10–35 pounds; use arm, hand, and finger dexterity to grasp and type for prolonged periods; and sit, reach, talk, and hear for prolonged periods.
Visual acuity to use a keyboard and computer monitor, operate equipment, and read materials for prolonged periods.

Nice To Haves

Steriles manufacturing experience is strongly preferred.

Responsibilities

Perform daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas to identify errors or deficiencies and ensure quality and compliance with site procedures and cGMPs.
Provide internal and external customer support.
Interact daily with personnel to assist with troubleshooting, documentation corrections or notes, and guidance on aseptic technique.
Foster a quality culture by helping personnel understand policies and controls.
Participate in the rapid response process and provide quality guidance for deviation events.
Ensure deviation events are escalated to the appropriate area and quality management.
Review and approve procedures, training documents, and forms of moderate to high complexity.
Review and approve deviations and change controls of moderate to high complexity.
Participate as the quality assurance representative in root cause analysis supporting deviation investigations of moderate to high complexity.
Perform quality batch record review and/or batch disposition.
Help identify continuous improvement opportunities.
Participate in practical process improvement (PPI) initiatives.