Quality Assurance / Quality Control Manager- Miami Gardens

Miami Gardens, FL - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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:

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 SOPs 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 SOPs.
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).
Bachelors 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.

Required Experience:

Manager

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 ensurin...

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 SOPs 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 SOPs.
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).
Bachelors 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.