Job Description
The Quality Associate will work closely with the QA team and is responsible for maintaining all labeling files in accordance with internal procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling regulations and process requirements. The Quality Associate must understand GMP and come from generic pharmaceutical, following SOPs diligently.
ResponsibilitiesMaintain all labeling files according to internal procedures.Coordinate labeling projects to ensure regulatory compliance.Provide guidance on labeling regulations and process requirements.Initiate, review, and implement label creation and updates with meticulous attention to detail.Provide regular updates on labeling projects to cross-functional departments to facilitate coordination for project completion timelines.Essential SkillsAbility to function well under pressure and balance multiple projects.Dedicated, detail-oriented focus in project initiation and management.Ability to take and follow directions.Familiarity with FDA Labeling guidelines (21 CFR).Excellent communication and organizational skills.Proficiency with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).Knowledge of global medical device labeling requirements.Additional Skills & QualificationsBachelor's degree or equivalent experience.Experience with translation activities.Team player and flexible to work as per priority.Work Environment
The role is situated within the generic pharmaceutical industry, providing a dynamic environment where teamwork and regulatory compliance are paramount. The work involves collaboration with various departments and requires adaptability to changing priorities.
Pay and BenefitsThe pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Basking Ridge,NJ.
Application Deadline
This position is anticipated to close on Jul 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.