Manager, Quality Assurance

Summary

Responsible for plant-level quality leadership and decision-making as it pertains to functions performed at the site. Team with Plant management and provide overall site management and coordination of the quality assurance program designed to ensure production of products in accordance with the master schedule and in compliance with established Government and Company standards. Provide an oversight role to manufacturing and packaging operations.

Essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
• Oversight of and responsibility for Quality issues and decisions affecting routine production.
• Ensure that all observations resulting from internal audits of plants are thoroughly reviewed and corrective/preventive actions are completed within agreed-upon dates.
• Ensure that non-conformances, deviations, customer complaints, and other quality related issues are investigated in a timely manner and corrective/preventive actions are assigned and completed as required.
• Ensure that batch records are reviewed, quality issues resolved, and NCRs have been investigated and properly closed prior to release to packaging and final release to distribution.
• Actively participate in regulatory inspections as directed by QA senior management, performing such duties as accompanying government officials including agency inspections and providing requested information in a timely and professional manner.
• Prepare department and individual goals that are in line with Company and departmental objectives.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations
• Plan and organize quality and reliability training activities for department and other company personnel.
• Assist in upgrading the knowledge and work performance of manufacturing operators by sharing SOP and GMP information and the related applicability.
• Execute SOP reviews and revisions for key QA procedures
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated working knowledge of statistics and their application to the Quality Assurance function.
• Demonstrated thorough knowledge and understanding of governmental requirements related to Good Manufacturing Practices and other legislation regulating the production operation.
• Demonstrated ability to communicate clearly and persuasively, both verbally and in writing.

EDUCATION/EXPERIENCE

• Bachelor's degree in Chemistry, Pharmacy or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
• Five years' experience in a supervisory or lead role in Quality Assurance or Quality Control in the pharmaceutical or other highly regulated industry.

Work Environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

• Stand, walk, sit, reach, talk, and hear.
• Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

• Normal office conditions.
• Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
• Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

We are an equal opportunity employer M/F/D/V.

Current Openings for Manager, Quality Assurance Jobs in Missouri (MO) at Nesher Pharmaceuticals (USA) LLC