Support QA for cosmetic and OTC drug manufacturing by reviewing batch records, performing in-process checks, supporting product release, investigating deviations and complaints, maintaining quality systems (SOPs, CAPA, change control), supporting audits and regulatory readiness, and assisting with QC data trending and continuous improvement.
Summary:
The QA Specialist I supports 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:
Qualifications:
Physical Requirements: • Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance. • Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts. • Good understanding of safety protocols and practices. • Willingness to work flexible hours, including shifts and weekends. • Ability to work in a fast-paced environment and adapt to changing priorities.
Salary Range: $23.00 to $25.00 (Non-Exempt)
Equal Opportunity Employer:
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
The QA Specialist I supports 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:
- Includes the following. Other duties may be assigned.
- Completes all tasks and assignments in a safe and timely manner.
- Strives toward continuous self improvement in personal productivity.
- Reviews batch records, specifications, and quality documentation.
- Conduct in-process checks and support final product release.
- Assists in investigations of and tracking of deviations, non-conformances, and customer complaints.
- Aids in reviews and tracking of quality systems documentation such as training, change controls, CAPA, audit commitments.
- Support internal audits and regulatory inspection readiness.
- Aids 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:
- 1 year 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) preferred.
- Basic 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
Physical Requirements: • Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance. • Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts. • Good understanding of safety protocols and practices. • Willingness to work flexible hours, including shifts and weekends. • Ability to work in a fast-paced environment and adapt to changing priorities.
Salary Range: $23.00 to $25.00 (Non-Exempt)
Equal Opportunity Employer:
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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