System One
Job Title: Regulatory Compliance Coordinator
Location: Morristown, New Jersey
Hours / Schedule: Monday - Friday, 8am - 5pm (some flex needed)
Type: Contract to Hire
Responsibilities:
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)
Requirements
2-5 years of experience in Quality Assurance or Regulatory Compliance in a regulated manufacturing environment (Pharmaceutical / Nutraceutical preferred)
Bachelor's Degree (Science, Quality, Engineering, or related field)
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 review
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
Benefits
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.
#M3
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.
Location: Morristown, New Jersey
Hours / Schedule: Monday - Friday, 8am - 5pm (some flex needed)
Type: Contract to Hire
Responsibilities:
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)
Requirements
2-5 years of experience in Quality Assurance or Regulatory Compliance in a regulated manufacturing environment (Pharmaceutical / Nutraceutical preferred)
Bachelor's Degree (Science, Quality, Engineering, or related field)
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 review
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
Benefits
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.
#M3
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.