Express Employment Professionals - San Diego
Regulatory & QA Specialist
Express Employment Professionals - San Diego, San Diego, California, United States, 92189
We are looking for a proactive and detail-oriented Regulatory & Quality Assurance Specialist to join our client’s OTC drug operations team. In this role, you will ensure full compliance with FDA OTC monograph requirements, cGMP regulations (21 CFR Parts 210/211), and relevant quality system standards. You will provide hands-on QA oversight across manufacturing, testing, and regulatory submissions, while driving continuous improvements to the Quality Management System (QMS) to strengthen product quality and regulatory readiness.
Responsibilities
Quality Assurance (QA): Review and approve Master Batch Records (MBRs), executed batch records, packaging records, and Certificates of Analysis (CoAs) for product disposition. Oversee deviation, OOS, OOT, complaint, and CAPA investigations to ensure timely closure and compliance. Support change control and risk management processes related to OTC drug products. Conduct internal audits and prepare for FDA inspections and third-party audits. Ensure product stability programs, labeling controls, and annual product reviews are compliant. Provide QA oversight for vendors, CMOs, and testing laboratories. Regulatory Affairs (RA): Maintain compliance with FDA OTC monographs, labeling regulations, and drug listing requirements. Support preparation, submission, and maintenance of electronic drug listings (NDCs) in FDA SPL format. Ensure OTC labeling and Drug Facts panels are accurate, compliant, and up to date. Monitor regulatory changes (e.g., FDA guidance, ICH updates) and communicate impacts to internal stakeholders. Assist with responses to FDA inquiries and deficiency letters. Cross-Functional Support: Collaborate with R&D, Manufacturing, QC, Supply Chain, and Commercial to ensure end-to-end compliance. Provide training on GMP, data integrity, and regulatory compliance to internal teams. Support product lifecycle management, including new product introductions and post-market compliance. Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field. 3–7 years of experience in GMP Quality Assurance and/or Regulatory Affairs (OTC, cosmetics, or pharmaceuticals). Strong working knowledge of FDA regulations: 21 CFR Parts 210, 211, 201 (labeling), and 11 (electronic records). Experience with OTC monograph products and FDA electronic drug listing (SPL/NDC) required. Hands-on experience with batch record review, deviation investigations, CAPAs, and audits. Excellent attention to detail, organizational skills, and ability to work cross-functionally in a fast-paced environment. Preferred Qualifications Experience with sunscreen or topical OTC products (21 CFR Part 352). Prior experience in a CMO/CDMO oversight role. Knowledge of ISO 13485, ICH Q10, and risk-based quality systems. Experience with QMS platforms. Proficiency indicators: Bachelor’s Degree Express Employment Professionals – San Diego
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Quality Assurance (QA): Review and approve Master Batch Records (MBRs), executed batch records, packaging records, and Certificates of Analysis (CoAs) for product disposition. Oversee deviation, OOS, OOT, complaint, and CAPA investigations to ensure timely closure and compliance. Support change control and risk management processes related to OTC drug products. Conduct internal audits and prepare for FDA inspections and third-party audits. Ensure product stability programs, labeling controls, and annual product reviews are compliant. Provide QA oversight for vendors, CMOs, and testing laboratories. Regulatory Affairs (RA): Maintain compliance with FDA OTC monographs, labeling regulations, and drug listing requirements. Support preparation, submission, and maintenance of electronic drug listings (NDCs) in FDA SPL format. Ensure OTC labeling and Drug Facts panels are accurate, compliant, and up to date. Monitor regulatory changes (e.g., FDA guidance, ICH updates) and communicate impacts to internal stakeholders. Assist with responses to FDA inquiries and deficiency letters. Cross-Functional Support: Collaborate with R&D, Manufacturing, QC, Supply Chain, and Commercial to ensure end-to-end compliance. Provide training on GMP, data integrity, and regulatory compliance to internal teams. Support product lifecycle management, including new product introductions and post-market compliance. Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field. 3–7 years of experience in GMP Quality Assurance and/or Regulatory Affairs (OTC, cosmetics, or pharmaceuticals). Strong working knowledge of FDA regulations: 21 CFR Parts 210, 211, 201 (labeling), and 11 (electronic records). Experience with OTC monograph products and FDA electronic drug listing (SPL/NDC) required. Hands-on experience with batch record review, deviation investigations, CAPAs, and audits. Excellent attention to detail, organizational skills, and ability to work cross-functionally in a fast-paced environment. Preferred Qualifications Experience with sunscreen or topical OTC products (21 CFR Part 352). Prior experience in a CMO/CDMO oversight role. Knowledge of ISO 13485, ICH Q10, and risk-based quality systems. Experience with QMS platforms. Proficiency indicators: Bachelor’s Degree Express Employment Professionals – San Diego
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