Job Description

Job Description

Job Description

Description:

Position Summary:

The purpose of this job is to: manage, plan, organize and direct the activities related to Quality Control to ensure timely completion of the functional tasks; manage the development and implementation of related programs to maximize efficiencies and effectiveness of the function and budgetary resources necessary to support the company goal while complying with regulatory requirements; operate in accordance with company policies and procedures, FDA Regulations, ISO Standards. Maintain oversight of manufacturing activities for quality compliance. Take immediate action to resolve issues and escalate to upper management as necessary. Review and approve product, process, and material related nonconformance for technical accuracy, completeness, and justifications supporting recommended actions to be taken.

Responsibilities

• Understands and communicates corporate vision, strategies, and goals to department personnel.
• Leads and mentors Quality Team providing support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement to Quality.
• Oversight and approval of nonconformances, complaints and CAPA’s, conduct problem solving and root cause analysis activities.
• Oversight and responsibility to ensure site maintains adherence to Quality KPIs (performance indicators and takes timely action to address adverse trends and deviations. Continuously monitors and assesses opportunities for improvement.
• Work collaboratively with Planning, Supply Chain, R and D Labs, Manufacturing, Validation, and Operations to drive continuous improvement.
• Interfaces directly with customers and suppliers to process returns and to ensure potential quality issues are eliminated.
• Oversees the quality performance and improvement of outside suppliers.
• Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
• Coordinates audit both internally and externally with regulatory agencies and customers
• Evaluate the effectiveness of vendor performance and take corrective action when necessary
• Exercises responsibility for QC personnel training and development and motivating supervised associates.
• Provides an ongoing educational program for associates concerning regulatory issues. Advises, consults with manufacturing and product development on issues of regulatory.
• Performs other duties and assignments as required.

Required Skills/Abilities

• Excellent written, verbal and interpersonal communication skills
• Prioritize multiple responsibilities and manage deadlines accordingly
• Acute attention to detail and high level of organization and accuracy
• Proactive nature – must want to learn and develop in the role
• Strengths in developing and maintaining customer relationships
• Able to work autonomously but must be able to work across teams
• Works in both office/lab and manufacturing environments.
• Must be able to handle sensitive related and proprietary information in a confidential manner.
• Experience in developing laboratory SOPs and revisions according to regulatory guidelines
• Strong knowledge of GMP, ISO, Data Integrity and safety guidelines
• Ability to analyze and solve problems
• Proficient with Microsoft Office

Required Education and Experience

• A minimum of a bachelor’s degree in Chemistry/ quality or related field
• A minimum of 5 years of regulatory affairs experience working in a personal care, cosmetics health care, pharmaceutical, or research
• A minimum of 3 years of Supervisory/Managerial experience.

Preferred Education and Experience:

• Fluent in Spanish

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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