Regulatory Compliance Coordinator

Job Title: Regulatory Compliance Coordinator
Location: Whippany, New Jersey
Duration: Contract to Hire
Hours: M-F 8-5 some flex needed

MUST HAVES:

• 2–5 years of experience in Quality Assurance or Regulatory Compliance in a regulated manufacturing environment (Pharma/Nutraceutical preferred)
• Bachelor’s Degree (Science, Quality, Engineering, or related field)2–5 years of QA or Regulatory experience in a regulated manufacturing environment
• Knowledge of packaging systems and regulatory compliance
• Experience training/coaching others on SOP compliance
• Working knowledge of 21 CFR Parts 111, 210, 211, and/or 820
• Hands-on experience with:
• CAPA management
• Change control
• Document control and batch record revie
• Internal and external audits
• Familiarity with QMS systems and compliance tracking tools
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook)
• Strong verbal and written communication skills
• Experience supporting regulatory/client inspections
• Ability to operate effectively in a fast-paced, 24/7 production environment
• Bachelor’s Degree in Science, Quality, Engineering, or related fields

• The Regulatory Compliance Coordinator is responsible for supporting and maintaining regulatory compliance functions in a 24/7 pharmaceutical manufacturing environment. The position is key to audits, policy/SOP updates, CAPA completion, change control processing, document control, training records, and complaint investigations.
• Support site-wide regulatory compliance functions
• Assist with internal/external audits (FDA, client, third-party)
• Maintain policies, SOPs, CAPA documentation, and change controls
• Investigate deviations and customer complaint
• Perform document control and batch record functions
• Analyze compliance metrics and escalate concerns
• Support QMS improvements and continuous improvement projects
• Assist in inspection readiness and training documentation
• Provide cross-functional QA support across departments

• Standard Office Computers

• Document Management Systems (QMS, ERP – preferred)

• General office equipment (copiers, scanners,

• System One, and its subsidiaries including Joulé, ALTA IT Services, 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.

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.