Quality Assurance Manager
Boca Raton, FL
Full Time
Beauty innovation starts here! An exciting opportunity has opened up to join the world’s leading partner for Turnkey Performance Product Solutions, Custom Formulation and Contract Manufacturing.
Job Title: Quality Assurance Manager
Reports to: Director of Quality Assurance
Support to: Quality Assurance, Planning, Operations
Key Responsibilities
1. Quality Assurance Oversight:
- Lead and manage the day-to-day operations of the QA department to ensure compliance with GMP (Good Manufacturing Practices) and other regulatory standards.
- Follow and promote adherence to current Good Manufacturing Practice (cGMP) procedures for the manufacturing of cosmetics and drugs under the following:
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- Over the Counter (OTC) drugs under 21CFR211
- ISO 22716 Good Manufacturing Practices for Cosmetics
- Drive continuous improvement in processes to enhance product quality and efficiency.
- Support Safety Compliance: Promote a culture where all team members support and follow safety rules and regulations. Ensure that safety protocols are integrated into all aspects of the QA process and that employees are trained to handle potential safety risks related to their tasks.
- Manage and provide leadership to any direct reports.
- Assist in internal audits as well as third-party regulatory, accreditation, or client audits.
- Contributes metrics and data to management review events such as Quality Council.
2. Product tracking and release:
- Execute thorough document review of bulk and finished batch records to ensure content completeness and accuracy, adherence to Good Documentation Practices, completion of paperwork packet and review of data from third-party test laboratories
- Release of product through business planning software (NetSuite)
- Maintenance of product status spreadsheets and databases
3. Team Leadership & Development:
- Lead, mentor, and develop the QA team to foster a culture of quality and compliance.
- Continually strive for professional improvement though certifications, webinars and research and help lead other team members to drive their professional growth.
4. Quality Systems Management:
- Ensure that the company’s Quality Management System (QMS) is robust and fully aligned with global regulatory standards.
- Coordinate internal audits, risk assessments, and provide guidance to departments on quality initiatives.
- Monitor and report on key performance indicators (KPIs) to senior management, ensuring any deviations are addressed promptly.
- Support CAPA (Corrective and Preventive Action) systems in response to audit findings or customer complaints, ensuring root cause analysis and appropriate actions are taken.
- Lead root cause investigations for quality issues and customer complaints, implementing corrective and preventive actions.
- Work cross-functionally with R&D, manufacturing, and supply chain teams to address quality concerns that could affect customer satisfaction or regulatory compliance.
- Work with the Quality Assurance department in initiating, investigating, writing, and closing of the following quality events:
- Change control
- Out of Specification (OOS) and Non-Conformance Reports (NCR)
- Corrective and Preventive Actions (CAPA)
- Deviations
- Customer complaints
- Investigations
5. Qualifications & Requirements:
- Education: Bachelor’s degree in a technological, natural sciences or other related field.
- Experience:
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- Minimum of 5-7 years of experience in Quality Assurance or Quality Control, with at least 2 years in a supervisory / managerial role in a regulated industry
- Skills:
- Previous experience in cosmetic, drug and / or other FDA regulated industry required.
- Excellent communication skills, both verbal and written. Technical report writing capability required.
- Ability to work at one’s own initiative and thrive in fast paced work environment.
- Excellent leadership, communication, and interpersonal skills.
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- Advanced written and verbal skills, with the ability to explain complex concepts clearly.
- Strong organizational and time management skills with the ability to manage multiple projects simultaneously.
- Proven experience with quality systems, documentation, and compliance audits.
- Knowledge of all applicable regulatory standards and ability to “lead by example” as a quality assurance team member.
- Advanced computer skills, including the usage of Microsoft Office applications.
- Acceptance to perform any other professional tasks as required by Cosmetic Solutions
Equal Employment Opportunity
Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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