Quality Specialist III

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.