Quality Specialist (1099/Contract)
Evermark, Hackensack, NJ, United States
Quality Specialist – Cosmetics & OTC Compliance
Location: hybrid-remote
Employment Type: Full-time Contract/1099
Summary
Detail‑oriented Quality Specialist with experience in cosmetics and/or OTC environments, responsible for managing corrective actions, conducting trend analysis, and supporting regulatory compliance activities. Proven ability to analyze quality data, verify effectiveness of CAPAs, and ensure compliance with MoCRA, FDA, and GMP requirements. Strong cross‑functional collaborator focused on continuous improvement and audit readiness.
Key Responsibilities
Identify trends and patterns in supplier nonconformances, providing insights for process improvement initiatives
Collaborate with cross‑functional teams to implement corrective and preventive actions (CAPA) to address customer complaint trends
Compile quality metrics and trend reports
Manage day‑to‑day quality relationships with contract manufacturers, ensuring timely completion of supplier nonconformance investigations and corrective actions
Oversee and review process validation, cleaning validation, equipment qualification processes at contract manufacturers
Ensure analytical method validation/verification aligns with OTC/USP requirements and governance standards
Perform technical assessments for change control
Administer eQMS and provide data analytics support
Qualifications
Bachelor’s degree in Chemistry, Biology, Engineering, or related field preferred
3–5+ years of experience in cosmetics, personal care, or OTC quality
Experience with CAPA systems, complaint handling, and root cause analysis
Technical Expertise
Working knowledge of Cosmetics GMP (Good Manufacturing Practices)
OTC regulatory requirements (21 CFR 210/211 and applicable monographs)
Proficiency in data analysis and trending tools (e.g., Excel, quality systems)
Core Competencies
Strong analytical and problem‑solving skills
Detail‑oriented with excellent documentation practices
Ability to interpret data and identify trends
Effective communication and cross‑functional collaboration
Strong organizational and time management skills
Preferred Qualifications
Experience in contract manufacturing or supplier quality environments
Experience supporting FDA audits or regulatory inspections
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Location: hybrid-remote
Employment Type: Full-time Contract/1099
Summary
Detail‑oriented Quality Specialist with experience in cosmetics and/or OTC environments, responsible for managing corrective actions, conducting trend analysis, and supporting regulatory compliance activities. Proven ability to analyze quality data, verify effectiveness of CAPAs, and ensure compliance with MoCRA, FDA, and GMP requirements. Strong cross‑functional collaborator focused on continuous improvement and audit readiness.
Key Responsibilities
Identify trends and patterns in supplier nonconformances, providing insights for process improvement initiatives
Collaborate with cross‑functional teams to implement corrective and preventive actions (CAPA) to address customer complaint trends
Compile quality metrics and trend reports
Manage day‑to‑day quality relationships with contract manufacturers, ensuring timely completion of supplier nonconformance investigations and corrective actions
Oversee and review process validation, cleaning validation, equipment qualification processes at contract manufacturers
Ensure analytical method validation/verification aligns with OTC/USP requirements and governance standards
Perform technical assessments for change control
Administer eQMS and provide data analytics support
Qualifications
Bachelor’s degree in Chemistry, Biology, Engineering, or related field preferred
3–5+ years of experience in cosmetics, personal care, or OTC quality
Experience with CAPA systems, complaint handling, and root cause analysis
Technical Expertise
Working knowledge of Cosmetics GMP (Good Manufacturing Practices)
OTC regulatory requirements (21 CFR 210/211 and applicable monographs)
Proficiency in data analysis and trending tools (e.g., Excel, quality systems)
Core Competencies
Strong analytical and problem‑solving skills
Detail‑oriented with excellent documentation practices
Ability to interpret data and identify trends
Effective communication and cross‑functional collaboration
Strong organizational and time management skills
Preferred Qualifications
Experience in contract manufacturing or supplier quality environments
Experience supporting FDA audits or regulatory inspections
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