Co-op, Site Compliance and Operations

Job Title: Manufacturing Co-op – Audit, Training & Compliance

Location: Cranbury, NJ

Job Summary:
The Manufacturing Co-op – Audit, Training & Compliance supports compliance-related activities within the manufacturing department, including audit readiness, training coordination, and adherence to GMP requirements. This role assists in maintaining inspection-ready status and ensuring timely completion of assigned compliance tasks.

Key Responsibilities:

• Support audit and inspection readiness activities, including walkthroughs, documentation review, and tracking of audit observations


• Assist in drafting and tracking audit responses, CAPAs, and action items


• Monitor training compliance in different departments and follow up on overdue training


• Coordinate with department training coordinators and support timely assignment and completion of SOP training in the learning management system (e.g., MC)


• Assist in maintaining GMP documentation, including logbooks, forms, and SOP alignment


• Support investigations related to training gaps as applicable


• Participate in routine area inspections to ensure adherence to GMP and facility standards


• Collaborate with cross-functional teams (QA, QC, F&E, Manufacturing) on compliance-related initiatives

Qualifications:

• Pursuing a degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related field


• Basic understanding of GMP principles and pharmaceutical manufacturing is preferred


• Strong attention to detail and organizational skills


• Good communication and ability to work cross-functionally


• Proficient in Microsoft Office (Excel, Word, PowerPoint)

Key Competencies:

• Attention to detail and data accuracy


• Accountability and proactive follow-up


• Understanding of compliance and quality mindset


• Ability to manage multiple tasks in a fast-paced environment

The anticipated salary range for this position is $20 to $30 an hour                

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.