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Job Title: CTO QA Label Specialist

Hours/Schedule: Wed-Sat- 4:00pm-2:00am

Compensation: $27.52- $34.96

Type: Contract

Overview

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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.

Requirements

• 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.

• 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 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

Education and Experience:

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.