Our client, a leading pharmaceutical company, is hiring a QA CTO Label Specialist, on a contract basis.
Job ID: 83032
Work Location:
Summit, NJ – 100% on site
Education/Experience:
- B.S. Degree required, 2 years relevant work experience
- Must have knowledge and experience with GMP, Quality, and compliance.
- Able 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.
Knowledge/Skills:
- 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 departments 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 efficiencies.
- 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.
- Interacts with internal and external cross functional teams.
- Represents department in internal and external cross-functional teams.
- Contributes to goals within the work group.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to produce data reports with precision.
- Able to multi-task.
- Able to support internal and health authority inspections of facility
Responsibilities:
- Supports all activities for the Label Control group.
- Responsible for issuing clinical and commercial in-process and final product labels for labeling
- operations.
- Responsible for ensuring 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 standard operating procedures (SOPs) related to job responsibilities define the steps
- necessary to complete tasks, etc. 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.
Pay: $32-$34/hr