American Health Packaging is the market leader in provided barcoded unit dose oral solids to the healthcare marketplace. We offer the most comprehensive UD line available with products from all the major therapeutic groups.
Located in Columbus, Ohio, American Health Packaging is a subsidiary of AmerisourceBergen and has been in business since 1991. The manufacturing facility is registered with the Food and Drug Administration (FDA) and complies with current Good Manufacturing Practices (cGMP). American Health Packaging is licensed by the Drug Enforcement Administration (DEA) to package Schedules II-V controlled substances. Position Summary:
Under general direction of the Vice President, Regulatory Affairs and Quality Systems, responsible for developing, revising and maintaining quality assurance systems to ensure compliance with cGMP's and contract customer requirements.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately. PRIMARY DUTIES AND RESPONSIBILITIES:
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- Leads and ensures compliance with cGMP's, DEA and OSHA regulations on the production shifts.
- Partners with manufacturing in ensuring cGMP compliance, as well as delivery of quality products, including improvement efforts in quality production.
- Oversees and manages the CAPA (corrective action, preventive action) system. Ensures actions and follow up are executed in a timely manner.
- Manages and develops new functionality as the system owner for the Document Management software system.
- Leads and manages the batch packaging Deviation program.
- Leads the Quality Systems team through direct management of the Sr. Quality Systems Managers who oversees the shift Quality Managers in production.
- Serves as lead regulatory escort, performs escort duties with contract packaging customers and FDA during audits.
- Leads and manages the supplier audit/certification program.
- Responsible for leading the efforts and compliance with Lean Six Sigma practices for the department. Provides support to continuous improvement activities as needed.
- Functions as back up to departmental Sr. Director of Regulatory Affairs or Vice President of Regulatory Affairs and Quality Systems when needed.
- Performs related duties as assigned.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- BS in a scientific discipline preferred; minimum of five (5) years in a cGMP facility in a Quality Assurance/Quality Control role.
- Certified LSS Black belt.
- Excellent oral and written communication skills. Ability to interact and communicate with staff at all levels
- Ability to effectively lead, manage and participate in cross-functional problem solving teams; advanced collaboration skills
- Advanced computer skills required
- Ability to read and understand the English language for the purpose of following instructions
- Ability to develop and maintain cooperative working relationships with others
- Ability to use good judgment in order to carry out detailed instructions
- Ability to work independently, as well as within groups
- Ability to handle a variety of tasks simultaneously
- Attention to detail