Job Description

Responsible for supervising the activities of MQA Specialists. Ensures accurate and timely certification of manufacturing batch record documentation. Ensures performance of audits and SOP/GMP compliance at the manufacturing facility. Performs investigations as required to ensure product quality. Performs analysis on quality indicating data and makes recommendations for improvement.

Key Responsibilities

• Supervises daily activities of MQA Specialists. Assures job objectives are met on a timely basis
• Updates and procures approval of job descriptions for department personnel.
  Performs and oversees the training of personnel. Effectively hires,
  develops, councils, manages and motivates staff. Writes and administers
  performance appraisals for department personnel.
• Assures standard operating procedures (SOPs) define the steps necessary to complete tasks. Writes review and updates SOPs.
• Assures timely execution of batch record certification function. Follow up with
  department management to ensure corrective action is implemented.
• Supports metrics for the facility. Collects, maintains, trends, and analyzes data.
• Develops systems to facilitate timely finished product disposition. Perform
  investigations as required. Follows up to ensure corrective action as
  implemented. Initiates/supports management meetings/projects to
  facilitate timely product disposition.
• Addresses daily quality concerns and questions. Offers recommendations as required. Performs investigations as necessary.
• Troubleshoots manufacturing problems and quality issues. Works with operations
  personnel to investigate, collect, and analyze data for, resolve and
  implement corrective action. Contacts supplier and/or outside laboratory
  for investigational support.
• Maintains knowledge of current GMPs and regulatory guidelines.
• Performs supplemental investigations and determines impact or product disposition

Qualifications

APPLY