ABOUT SAFECOR HEALTH

Safecor Health, LLC is the nation’s largest independently owned repackaging operation dedicated to providing unit dose medications to hospitals and long-term care facilities. We facilitate a more efficient and safe delivery of medications to patients in those important care settings. Safecor Health repackages in most oral dosage forms including liquids, oral solids and over bagging of items for use in automation deployed throughout hospitals from two facilities (Columbus and Woburn)

THE ROLE OF THE QUALITY ASSURANCE MANAGER

The Quality Assurance Manager is responsible for managing the breadth of quality assurance and assisting with the state licensing functions for the Company. Quality Assurance Manager is the key manager that ensures compliance with the FDA working with Quality Assurance counterparts in all locations.

Plans, coordinates, represents, and directs quality program designed to ensure continuous production of products consistent with established standards. Organizes and strategizes the quality management activities, such as process and product approval, implementation of all FDA requirements, and budget activities.

RESPONSIBILITIES

• Establish, implement, and maintain FDA compliant Quality Systems - (21 CFR, parts 210, 211 & FDA Guidance).
• Develop, establish, implement, and maintain the processes needed for Quality Systems to function effectively.
• Prepare and assemble documentation for 3rd party accreditation bodies (e.g. VAWD).
• Respond to all observations and comments resulting from an inspection by a government or 3rd party agency. Identify and effect changes in a timely fashion as committed to the Inspection Group (DEA, FDA, etc.).
• Promote quality achievement and performance improvement throughout the organization by:
  • Establish quality metrics
  • Track and report progress including identifying trends
  • Label errors - internal
  • Deviations
  • Incidents (complaints)
  • CAPAs
• Assess product and component specifications of the company and its suppliers and compare with customer requirements.
• Oversight responsibility for systems such as:
  • Training (S.O.P.s, forms, CGMP)
  • Creating and managing SOP, Forms, Work Instructions and Protocols
  • Change control
  • Records requirements
  • Facilities requirements (including temperature and water system oversight)
  • Incoming inspection, receiving, storage and segregation
  • Equipment controls and validations (including ERP system)
  • Process controls and validations
  • Labeling control
  • Complaints
  • Recalls
  • Vendor Qualifications and Vendor List
  • Coordinate Management Review
• Oversight of Quarterly batch record audits to assure accuracy and consistency of inspection criteria and procedural adherence on the repackaging operations.
• Report periodically to top management on performance of Quality Systems and improvement needs.
• Coordinate and/or perform internal and external audits. Report results and assure that corrective actions are completed in a timely fashion.
• Proactively participate in identifying and implementing process improvements.
• Review and approve all change orders, deviations, incident reports, and CAPAs.
• Collaborate with Operations, New Business Development, Sales and Quality Control to identify quality issues and develop and implement action plans to resolve all issues.
• Oversight of equipment file maintenance and assure that calibration/PM schedules are maintained.
• Assist to ensure that all documentation for State licensing information is accurate and is completed in a timely manner.
• Oversight for maintaining all training files and keeping employee training records current.
• Interprets quality philosophy to key personnel in the organization.
• Formulates and maintains quality objectives complementary to Safecor Health policies and goals.
• Play active role on quality management teams within the organization.
• Analyzes department budget requests and allocates operating budget.

EDUCATION & EXPERIENCE

• Bachelor’s degree in chemistry or any other life sciences
• 5-7 years of experience in the Pharmaceutical Industry
• 2-3 years supervising or managing employees.

KNOWLEDGE, SKILLS & ABILITIES

• FDA expectations and requirements
• ICH Guidelines
• State and DEA regulatory knowledge preferred.
• Ability to matrix, manage people, processes and outcomes
• Extremely well organized, project management orientation
• Excellent verbal and written communication
• Organization, planning, and prioritizing
• Self-Motivated, ability to work in a team environment and autonomously.
• Working knowledge of Master Control System, preferred
• Prior experience developing and implementing a Quality System
• Experience managing FDA inspections.

COMPETENCIES

• Strong, positive communicator (verbal and written) and collaborator. Able to develop and maintain positive relationships with customers, employees, officials, and other stakeholders.
• Learns and adapts with the organization.
• Demonstrates strong emotional intelligence and self-awareness.
• Shows accountability for actions and decisions and accepts responsibility for results.
• Persuasive verbal abilities/skills to influence and enable customers to be active participants in the implementation process.
• Is solutions-oriented, while balancing organizational and customer needs.
• Demonstrates a strong bias for action in their daily work and strives for excellence.