Quality Specialist III

About the role

• Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

About the role

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.

Position Summary

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.

Key Responsibilities

• Performs daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs.
• Provides internal and external customer support
• Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
• Fosters quality culture by aiding personnel in understanding application of policies and controls
• Participates in rapid response process and provides quality guidance for deviation events
• Ensures escalation of 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 process and/or batch disposition
• Aids in identification of continuous improvement opportunities
• Participates in practical process improvement (PPI) initiatives

Qualifications

• BS/BA in a scientific or related field required.
• 5+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred.
• 2+ years in one or more of the following: Quality Engineering, Compliance, Regulatory Affairs.
• Equivalent combinations of training and relevant work experience may be considered if at least a bachelor degree is acquired.
• Previous experience in a cGMP environment.
• Able to maintain focus and prioritize in a fast paced and evolving environment.
• Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters.
• Confirmed problem solver and effective decision maker.
• Strong organizational, presentation, meeting facilitation, and technical writing skills
• Excellent communication (verbal and written) skills
• Outstanding attention to detail and able to work in a fast-paced environment.
• Demonstrated ability to function independently and as part of a team with exceptional interpersonal skills
• Strong computer proficiency skills in MS Office, TrackWise, and SAP System or equivalent
• Ability to work extended hours, especially during health authority inspections, assessments, and audits

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 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.