The QA Specialist II supports and drives the quality assurance activities for the manufacturing of cosmetic and OTC drug products. This role ensures compliance with FDA regulations, customer requirements, and internal quality standards. The ideal candidate will be detail-oriented, organized, and eager to grow within a fast-paced, regulated manufacturing environment.
Essential Duties and Responsibilities: Complete all tasks and assignments in a safe and timely manner. Strives toward continuous self improvement in personal productivity. Review and approve batch records, specifications, and quality documentation. Conduct in-process checks and support final product release. Leads and assists in investigations of deviations, non-conformances, and customer complaints. Drives reviews and tracking of quality systems documentation such as training, change controls, CAPA, audit commitments. Support internal audits and regulatory inspection readiness. Assists and leads efforts to ensure compliance with GMP, FDA regulations (21 CFR Parts 210/211), and ISO 22716 for cosmetics and OTC drug products. Help maintain and update SOPs and quality documentation. Collaborate with cross-functional teams to support continuous improvement initiatives. Maintain accurate and organized quality records. Aids in collection, analysis and trending of QC data and Quality metrics Preferred Skills: Exposure to 21 CFR Parts 210/211 and ISO 22716. Experience in a contract manufacturing setting. Familiarity with OTC monograph compliance and labeling. Willingness to learn and grow within a regulated industry.
Qualifications: Minimum 3 years of experience in a QA or regulated manufacturing environment preferred (cosmetics or OTC drugs a plus). Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences). Working knowledge and understanding of GMP, FDA regulations, and quality systems. Strong attention to detail and organizational skills. Effective written and verbal communication skills. Proficiency in Microsoft Office and familiarity with electronic quality systems is a plus. Maintains an exemplary attendance and punctuality performance record. Adheres to all Prime Personnel Policies as established by the company.
Rate range: $25.00 to $30.00
At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.
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