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
Skills Required
- Basic understanding of GMP, FDA regulations, and quality systems
- Strong attention to detail and organizational skills
- Effective written and verbal communication skills
- Maintains exemplary attendance and punctuality
- Ability to lift and move objects up to 25 pounds and perform physical tasks (stand, walk, bend, stoop)
- Willingness to work flexible hours, including shifts and weekends
- 1 year of experience in a QA or regulated manufacturing environment (cosmetics or OTC drugs a plus)
- Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences)
- Proficiency in Microsoft Office
- Familiarity with electronic quality systems
- 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
What We Do
We’re Prime Matter Labs, a beauty and personal care contract manufacturer with 40 years of experience working with amazing brands to create award-winning products recognized by the media and loved by consumers. In partnership with our customers, we are taking the lead in the beauty and personal care industry by being innovative in the processes and technologies we use and the products we create together. We offer our customers a full set of end-to-end capabilities from concept development to shipping, with critical attention to the steps in between including formulation, testing, quality control, packaging, manufacturing, and filling. With customers across Indie, Emerging and Established brands, we work on a variety of projects including custom development, reverse engineering, stability and efficacy improvement, and formulation clean-up to meet natural and organic criteria. We consistently invest in R&D, technology, our facilities, and our team, to enhance our capabilities. Our R&D chemists have developed thousands of best-in-class skin, hair, body and sun care formulations, leveraging innovative technologies and ingredients. With one of the broadest sets of certifications and full in-house testing capabilities, our facility is one of the few in the country that can truly deliver your entire personal care line end-to-end. We deliver a level of service, support, and transparency unmatched in the industry, and our project management team can handle projects of any size or complexity with ease and meticulous precision. From idea to launch - as production partners, we want you to shine. To see open positions, please go to our website at: https://bit.ly/2TgRbY4 Signup for our monthly newsletter at: http://eepurl.com/hTcbqX Find all our social channels here: https://withkoji.com/@PrimeMatterLabs
