Quality Assurance / Quality Control Manager- Miami Gardens chez Prime Matter Labs
Prime Matter Labs · Miami Gardens, États-Unis d'Amérique · Onsite
- Professional
- Bureau à Miami Gardens
Job Summary:
The Quality Assurance and Quality Control Manager will oversee our comprehensive quality operations for cosmetics and OTC drug manufacturing. This hands-on leadership role combines strategic quality system management with operational oversight of testing and inspection activities, ensuring product safety, efficacy, and regulatory compliance throughout the manufacturing lifecycle.
The ideal candidate will manage both quality assurance functions and quality control operations, leading a team responsible for testing protocols, material release processes, and compliance with FDA regulations and GMP standards. This position requires a detail-oriented leader who can balance operational excellence with regulatory requirements in a fast-paced, client-focused manufacturing environment.
Essential Duties and Responsibilities:
Qualifications:
Preferred Skills:
Physical Requirements:
Salary Range:
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.
Postuler maintenant
The Quality Assurance and Quality Control Manager will oversee our comprehensive quality operations for cosmetics and OTC drug manufacturing. This hands-on leadership role combines strategic quality system management with operational oversight of testing and inspection activities, ensuring product safety, efficacy, and regulatory compliance throughout the manufacturing lifecycle.
The ideal candidate will manage both quality assurance functions and quality control operations, leading a team responsible for testing protocols, material release processes, and compliance with FDA regulations and GMP standards. This position requires a detail-oriented leader who can balance operational excellence with regulatory requirements in a fast-paced, client-focused manufacturing environment.
Essential Duties and Responsibilities:
- Develop, implement, and maintain, along with your team, robust Quality Management Systems (QMS) tailored to the needs of the business, including deviations, complaints, change control, CAPA, APQR, Out of specifications, training, document control and internal audit program.
- Ensure compliance with GMP, FDA regulations (21 CFR Parts 210/211), and ISO 22716 for cosmetics and OTC drug products.
- Oversee the testing of bulk formulations, and finished products to ensure consistency, safety, and efficacy.
- Create and implement incoming inspection protocols for packaging, raw materials, and finished goods.
- Investigate and resolve quality issues, including product non-conformance, consumer complaints, and manufacturing deviations.
- Lead root cause analyses and corrective/preventive action (CAPA) initiatives.
- Collaborate with cross-functional teams to support continuous improvement initiatives.
- Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements.
- Control the quarantine and release of Raw Materials, Components, and Finished Goods in accordance with GMPs and PML SOP's.
- Drive collection, analysis and trending of QC data and Quality metrics
- Drives internal audit program, as well as regulatory and customer audit inspection readiness.
- Provides training for employee development.
- Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process.
- Train and mentor cross-functional teams on quality standards and best practices.
Qualifications:
- Minimum 5 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).
- Proven ability to work in a fast-paced, client-focused environment.
Preferred Skills:
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/ 210/ 211), including data integrity and practices.
- Experience working with cross-functional technology teams and enterprise systems.
- Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
- Strong attention to detail and organizational skills.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Office and familiarity with electronic quality systems.
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:
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.
Postuler maintenant
