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Job details

Quality Manager

SUMMARY DESCRIPTION

The Quality Manager develops, implements, and manages companywide quality systems. Provides quality management, expertise, and direction regarding quality processes and systems to drive continuous improvement in support of quality and compliance objectives. The Quality Manager supervises a team of Quality Control and Quality Assurance employees.

PERFORMANCE EXPECTATIONS

Support the implementation and maintenance of the quality management system
Oversee companywide continuous improvement as related to the QMS and all applicable regulations (GMP, ISO)

Ensures compliance with all applicable FDA, OTC, ISO, EPA requirements.
Lead and participate in formal problem solving processes, conduct root cause analysis and corrective action investigations
Manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards
Oversee product dispositions including tagging and quarantine procedures for rejection of in-process, finished product, and component receiving inspection areas. Authorizes rework, scrap, or return to vendor decisions

Foster the creation and application of improved quality methods, systems, and solutions to increase product quality, production efficiency and customer satisfaction
Manage quality compliance programs to ensure issue resolution and success

Proposes corrective actions to improve compliance with quality specifications
Recommends new or improved quality control methods, procedures, and/or standards
Manages Quality Control and Quality Assurance staff in their day-to-day work performance
Ensures that project/department milestones are met by analyzing data on relevant performance indicators
Assist in audit preparations as needed

Reviews out of specification investigation reports documenting problems observed in meeting quality standards or SOP’s
Manages the storage and retrieval of work order history records and finished good certificates of analysis.
Organizes laboratory inventory, ensures proper stock and ordering of laboratory needs
Possess strong interpersonal skills with the aptitude to be a team player and leader: setting a professional tone and establishing a cooperative partnership in all departments throughout the company

MEETING PARTICIPATION

Production Meeting
Quality Control Team Meetings

Any others as requested

AUTHORITY

This position reports to the head of the Quality Management System and closely collaborates with Manufacturing, Purchasing, Marketing, Administration and the Research and Development teams.

SUPERVISORY RESPONSIBILITY

Quality Control

Quality Assurance

CLASSIFICATION

This is a full-time exempt role

EDUCATION

Bachelor’s Degree

WORK EXPERIENCE

5+ years employed in Quality, Regulatory, or related field in a cGMP Facility

2+ years in supervisory/management preferred

Bilingual (Spanish) a plus

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