Quality Assurance Label Specialist

Delivery Lead - Recruitment at Integrated Resources, Inc (IRI)

Pay Range: $32 - $34.96/hr

• Knowledge and experience with GMP, Quality, and compliance.
• Ability to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
• Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
• Must be time organized and possess an independent mindset.
• Good understanding of electronic document management and manufacturing execution systems.
• Has advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve overall process/project.
• Proposes solutions for complex issues and works with management to resolve; follows established procedures and performs work as assigned.
• Builds relationships and effectively communicates internally within the function and with internal and external cross‑functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to produce data reports with precision.
• Able to support internal and health authority inspections of facility.

B.S. Degree required, minimum 2 years relevant work experience.

• Supports all activities for the Label Control group.
• Responsible for issuing clinical and commercial in‑process and final product labels for labeling operations.
• Ensures accurate printed information on labels in compliance with health authority requirements.
• Coordinates with production teams to ensure timely issuance of labels.
• Performs training of label control and issuance requirements for internal personnel as needed.
• Ensures SOPs related to job responsibilities define the steps necessary to complete tasks; writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.

Mid‑Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing and Biotechnology Research