QA Specialist

Job Description

Job Description

Job Title: QA Regulatory Affairs Specialist

Job Description

This position requires reviewing label content to ensure accuracy, consistency, and compliance. The role involves using labeling software to prepare and submit SPL, collaborating with customers for private labeling, and communicating labeling requirements and timelines to internal stakeholders.

Responsibilities

• Coordinate label approvals and manage version controls and updated labeling.
• Support change control processes related to labeling updates.
• Coordinate labeling projects to ensure regulatory compliance.
• Facilitate project completion through effective and detailed project management.
• Provide guidance to team members on labeling regulations and process requirements.
• Initiate, review, and implement label creation/updates with extreme attention to detail.
• Identify and recommend process improvements to enhance business practices.
• Provide regular updates regarding labeling projects to cross-functional departments.
• Foster collaborative, efficient, and effective working relationships with internal teams.
• Prepare and submit Annual Reports.
• Mentor team members and act as a recognized resource to local team.
• Perform other duties as assigned based on business requirements.

Essential Skills

• Quality assurance expertise.
• Knowledge of FDA regulations.
• Understanding of SOPs.
• Ability to partner with members across departments like Regulatory and Quality to ensure compliance.
• Proficient knowledge of GMP and Quality Management Systems.
• Computer literacy in Windows applications and MS Office (Word, Excel, Outlook).

Additional Skills & Qualifications

• A minimum of a BS in a scientific discipline.
• 1-3 years of experience in pharmaceutical manufacturing.
• 1-2 years of quality experience with pharmaceutical FDA submissions.

Work Environment

This role operates within a GMP environment on the QA team, offering room for growth. The position requires collaboration with teams based both in the US and India.

Pay and Benefits

The pay range for this position is $80000.00 - $87000.00/yr.

401k is really great! We offer 3% contribution regardless of contribution and offer an additional match up to 1.5%. So if they contribute 1.5% they get 6% toward 401k.

Workplace Type

This is a fully onsite position in Basking Ridge,NJ.

Application Deadline

This position is anticipated to close on Sep 26, 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 [email protected] for other accommodation options.