The following functions describe the essential duties of this role. Individuals in this role may not perform all these duties, or may perform additional, related duties not listed here.
ESSENTIAL SKILLS:
- Planning, directing, and coordinating the packaging of products in compliance with Company goals and Quality objectives.
- Oversee quality assurance activities concerned with the packaging of products, materials, processes, inspections, corrective actions, and preventive actions.
- Providing leadership and expertise to implement, improve and maintain packaging quality systems including compliance to Good Manufacturing Practices
- Manages the quality assurance and quality control processes
- Performs quality review and approval of executed Packaging Batch Records, data, protocols, and/or reports.
- Performs review and approval of labeling for compliance with regulatory standards
- Performs review and release of all materials used for packaging processing including drug product, packaging components and labeling.
- Leads and participates in investigations, deviations, discrepancies, technical problems, complaints and non-conformance of materials and processes.
- Establishing and controlling conditions of production to ensure quality specifications are met and satisfy customer requirements.
- Organizing and directing workflow for satisfying production requirements
- Responsible for validation activities associated with the development of new and existing products, processes, and systems for packaged products.
- Develop and implement quality procedures and processes.
- Educate and train the packaging and quality employees on quality standards applicable to the Company.
- Oversees equipment calibration program and monitoring; equipment qualification program and monitoring including maintenance of all applicable documentation.
- Coordinate and monitor operational compliance with Quality Management System.
- Manage compliant Corrective Action / Preventive Action processes.
- Maintains facility quality records and procedures.
- Scheduling and participation in internal audits
- Participation and support of external regulatory inspection
- Identifies processes requiring development to maintain continual improvement of process performance and product quality
- Identifies and mitigates single points of failure
- Provides support in all Quality and Compliance areas, as required
EMPLOYMENT REQUIREMENTS
- At least 18 years of age
- Must pass pre-employment background check and drug screen
- Frequent lifting of 15-60 pounds
- Punctual and reliable in attendance