Director Of Quality Jobs

Walton, KY.

Full Time Position

Job Summary:

Independent from Operations. Maintains a quality system that meets all regulatory requirements. Through administration of Quality Assurance & Control activities, and process improvement initiatives, assures that products sold by the company meet all customer needs and expectations while supporting all other objectives. Ensures compliance with all quality system activities. Plans and coordinates all aspects of quality assurance activities. Communicates policies and procedures in support of the business. Has the authority to shut down operations or hold shipment anytime compliance is not met.

Manages the Internal Audit Program, the CAPA Process, the Document and Data/ Records Control, the Quality System Change Control Process, the Non-Conforming Material reports, and approval of potential suppliers. Responsible for Quality Review of Batch Record for release of product. Maintains all Quality System Records.

Must have skills required to understand Quality Systems to cGMP. Performs all tasks in a safe manner observing cGMP and quality standards.

Responsibilities:

• Ensure systems for validation of new and changes to current product processes and equipment.
• Handles nonconforming products.
• Responsible for hiring, retention and development of quality staff.
• Ensures systems are in place and functioning for quality and integrity of raw materials, in-process, and finished-product in accordance with standards and specifications.
• Performs registrations and other compliance activities.
• Lead quality team to ensure all staff is competently performing their duties as evidenced by findings of a program of monitoring, tracking and trending of key metrics.
• Maintains Document and Data/Records Control.
• Establishes, maintains and continually improves the overall quality system.
• Responsible for Quality Review of Batch Record for release of product.
• Hosts Audits.
• Manages Quality System Change Control Process.
• Establishes and maintains the quality management system.
• Ensure Product Quality for compliance.
• Performs and reports to Management Review Quality System performance.
• Maintains all Quality System Records.
• Carries out supplier quality surveys and audits.
• Some administrative activities may be required as needed.
• Analyzing, and interpreting production and quality performance data.
• Determines acceptability, condition and physical tests of product raw material & disposition of finished.
• Reviews and approves other documents: QC sheets, Lab documents, Certificates of Analysis.
• Trains and provides guidance to cGMP Pharmceutical/FDA Compliance.
• Maintains all Quality System Records.
• Lead investigations to determine root causes, corrective/preventative actions and appropriate coordination/leadership of process improvements.
• Performs trending analysis on internal and external failures.
• Performs inspections and testing in accordance with the quality plans.
• Experience in managing quality system activities.
• Manages the CAPA Process.

Qualifications:

• Ability to train and foster team environment to all employees.
• Detail oriented.
• Computer skills, includes Microsoft Office.
• Ability to work efficiently in fast-paced, high-volume environment.
• Ten or more years required in Quality Assurance.
• Ability to perform systems, process, and product audits.
• Ability to maintain any Quality System Documentation and Records..
• Bachelor’s Degree in business, management or engineering.

To apply for this position, please send cover letter and resume to: [email protected]