New Jersey Staffing
Regulatory Compliance Coordinator
New Jersey Staffing, Convent Station, New Jersey, us, 07961
Regulatory Compliance Coordinator
Location: Morristown, New Jersey Duration: Contract to Hire Hours: M-F 8-5 some flex needed MUST HAVES: 25 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) 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 Bachelor's Degree in Science, Quality, Engineering, or related fields 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 complaints 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 System One, and its subsidiaries including Joul, 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 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 Duration: Contract to Hire Hours: M-F 8-5 some flex needed MUST HAVES: 25 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) 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 Bachelor's Degree in Science, Quality, Engineering, or related fields 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 complaints 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 System One, and its subsidiaries including Joul, 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 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.