Quality Control and Assurance Director, Boca Raton

Quality Control and Assurance Director

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Who we are:

Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market.

Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formulization, graphic design, manufacturing, packaging and delivery.

Senior Director Quality Assurance Job Overview

Seeking an accomplished and integrity-driven quality professional offering over 20 years of Laboratory Management, Quality Systems Management (QSM), and Compliance experience in highly regulated sectors. The Senior Director of Quality will create and maintain a quality culture throughout the entire corporation. In addition, this position will develop and lead the business strategic quality plan in collaboration with the Executive Leadership Team (ELT) and other business unit senior leaders. This role provides strategic decision-making, leadership, planning, and prioritization to meet business and quality/compliance objectives.

The Senior Director of Quality Assurance will focus on influencing how the functional vision and implementation plans align with the core strategic vision and business objectives.

Responsibilities

Analyzes data to identify process improvement opportunities

Documents improvement action plans for processes and projects assigning the responsibilities to the various teams

Carries out project review meetings to ascertain progress

Works on Client Quality requirements to identify adequate process controls

Establishes Quality Assurance Plan for new projects

Studies processes, documents the flow and identifies opportunities to automate, or eliminate steps leading to improved turn-around-time.

Designs dashboards for reporting

Coordinates with various internal teams to drive actions

Carries out Root Cause Analysis of errors to prepare action plans

Trains, mentors and guides other members in the team on various Quality concepts

Maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.

Implements and acts in accordance with the organization’s information security HR and corporate policies.

Maintains quality assurance staff by recruiting, selecting, orienting, and training employees.

Protects assets from unauthorized access, disclosure, modification, destruction or interference.

Oversees the production process, ensuring compliance with industry standards, and managing quality assurance processes.

Develops and implements a comprehensive quality control plan, including procedures, processes, and guidelines to ensure that products meet quality specifications and adhere to regulatory requirements.

Heads process monitoring and improvement: Monitor production processes to identify any deviations from the established quality standards, investigate root causes, and initiate corrective actions. Continuously seek ways to improve processes to enhance product quality and reduce waste.

Quality assurance: Develop, implement, and maintain a robust quality assurance system that ensures products are consistently manufactured according to predefined specifications and in compliance with applicable regulations and standards (e.g., GMP, ISO, and FDA).

Documentation: Create, maintain, and update all necessary quality control and quality assurance documentation, including standard operating procedures (SOPs), batch records, quality control reports, and certificates of analysis (COTraining and development.

Ensure that all personnel involved in the production process receive appropriate training in quality control procedures, equipment operation, and safety protocols. Regularly review and update training materials to keep them current and relevant.

Equipment calibration and maintenance: Ensure that all equipment used in production is properly calibrated and maintained to guarantee accurate and reliable results. Schedule and oversee regular equipment maintenance and calibration activities.

Inspection and auditing: Conduct regular internal audits and inspections to ensure adherence to quality control procedures and regulatory requirements. Prepare for and participate in external audits by regulatory agencies and clients.

Supplier management: Evaluate, select, and monitor suppliers to ensure that raw materials and components meet quality specifications and comply with industry standards. Work closely with suppliers to address any quality issues that may arise.

Investigate and address customer complaints related to product quality, initiating corrective actions as necessary to prevent similar issues from occurring in the future.

Reporting: Generate regular quality control reports to track key performance indicators (KPIs) and present findings to senior management. Communicate with cross-functional teams to ensure that quality objectives are understood and achieved.

Leading, managing, and supervising a team of quality control inspectors. This involves: Recruitment and selection: Hire and onboard new quality control inspectors as needed, ensuring they possess the necessary skills, knowledge, and experience to effectively perform their duties.

Training and development: Provide ongoing training, guidance, and support to the quality control inspectors to help them understand their roles and responsibilities, as well as keep them up to date with industry standards and best practices.

Performance management: Set performance goals and objectives for the quality control inspectors, monitor their progress, provide regular feedback, and conduct performance evaluations. Address any performance-related issues promptly and effectively.

Delegation and task assignment: Assign specific tasks and responsibilities to the quality control inspectors based on their expertise, ensuring that all aspects of the quality control process are adequately covered.

Communication and collaboration: Foster an open and transparent work environment that encourages communication and collaboration among the quality control team members. Hold regular team meetings to discuss ongoing projects, address concerns, and share updates.

Motivation and engagement: Create a positive work atmosphere by recognizing and rewarding outstanding performance, addressing team concerns, and providing opportunities for professional growth and development.

Requirements Skills, Abilities, And Experience

Demonstrated success in creating and maintaining a culture of quality in a contract manufacturing organization

Broad system, production, and supply chain experience that shows a proven track record of leading and managing quality & reliability requirements

Knowledgeable and experienced in performing internal and external quality audits.

Site liaison, coordinator, and lead for all current and future regulatory agencies.

Knowledgeable and experienced in planning, coordinating, and leading QMS management reviews.

Knowledgeable and experienced in producing Annual Product Reviews for OTC formulas.

Root cause / corrective action expertise

Create and communicate an overall vision for quality within the company, setting goals and recommending organizational changes to achieve these goals.

Communicate the company’s quality system to customers.

Create an environment conducive to continuous quality improvement and implement systems to nurture quality excellence.

Direct activities of company-wide quality staff and departmental activities to ensure product quality through test procedures and processes.

Lead and facilitate workshops that provide immediate improvement results.

Provide leadership and guidance to the quality and contract manufacturing teams, fostering a culture of excellence, collaboration and continuous improvement.

Preferred Qualifications:

Minimum of 10 years of experience in quality assurance and quality control

Minimum bachelor’s degree in chemistry, biology, microbiology or similar life sciences or technical field such as engineering, mathematics, etc.

Detail-oriented, analytical, and able to manage multiple tasks in a fast-paced environment.

Extensive knowledge of FDA regulated industries

Strong facilitation, influencing, organizing, and presentation/communication skills.

Well-developed written and verbal communication skills.

Hands-on experience with all levels of manufacturing, formulation and quality assurance.

Excellent at regulations interpretation and implementation.

Skill sets include strong analytical and problem-solving abilities with a propensity for instituting rapid change in difficult situations.

Positive, team-focused approach and proven leadership track record, including people development and project management.

A demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives.

Experience and understanding of FDA Regulations & Audits, Title 21 of CFR 700, 820, 211, ISO Standards, Organic Certification, GMP, ISO 17025:2017

General Requirements for the Competence of Testing and Calibration Laboratories

FL Department of Health & FL Department of Agriculture and Consumer Services

Strong tenure in previous positions.

Experience on both sides of the audit table. Experienced third party / client auditor.

Experience with turnarounds of Quality Assurance Units resulting in successful third-party audits, quality accreditations and overall company growth.

Cosmetic Solutions LLC. is committed to equal employment opportunity for all employees and applicants for employment without regard to age, color, creed, disability status, gender, national origin, race, religion, sexual orientation or veteran status, or any other legally protected status.

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Location:: Boca Raton

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