QA CTO Label Specialist

Job Title: QA CTO Label Specialist
Location: Summit, NJ
Type: Contract
Compensation: $27.52 - $34.95/hr
Contractor Work Model: On-Site
Hours: Sun-Wed 3:30pm-2:00am (starting 29-Mar-2026, work hours will change to 6:00pm-6:30pm)

Overview
Global pharma company looking to hire experienced Label Specialist to join their Quality team. Must bring a minimum of an AS Degree and 2 years of experience with labelling in a GMP environment.

Responsibilities

• Support all activities for the Label Control group, including issuing clinical and commercial in-process and final product labels for labeling operations.
• Ensure accurate printed information on labels in compliance with health authority requirements.
• Coordinate with production teams to ensure timely issuance of labels.
• Perform training of label control and issuance requirements for internal personnel.
• Write, review, and update SOPs related to job responsibilities and tasks.
• Support new drug product launches, new market activities, and other quality management initiatives.
• Assist during internal and health authority inspections and audits of the facility.
• Maintain knowledge of current GMPs and regulatory guidelines related to label control, change control, product complaints, deviations, investigations, and CAPA management.
• Support supplemental investigations and projects as required by management.

Requirements

• Minimum of an Associate degree; B.S. degree preferred with at least 2 years relevant experience.
• Minimum 1 year of labeling experience in a cGMP/FDA regulated environment preferred.
• Experience with Crystal Reports and BarTender is preferred.
• Strong communication and customer service skills.
• Over 1 year of experience in biopharma and quality areas.
• Over 1 year of labeling experience.
• Proficiency in MS Office 365 for at least 3 years.
• Ability to support 7 days/24 hours operations, including holidays and weekends.
• Must have attendance and reliability given the supporting shift schedule.

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.