Advisor, Quality Compliance

Cardinal Health•Fife, WA

About The Position

Responsible for the implementation and execution of the Cardinal Health Quality System for the following sites including any annexes or associated locations: o Fife, Washington Medical Distribution o Portland, Oregon including At Home and Velocare o Anchorage, AK Medical Distribution Regulatory Management is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact. Leads and directs efforts to assess the implementation of Quality Systems to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency. Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements. Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance. Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters. Monitors Federal, State, and local regulatory activities to implement new company procedures or update existing procedures to facilitate compliance. Serves as liaison with local, state, accreditation and federal government agencies.

Requirements

Bachelors in related field, or equivalent work experience, preferred
4+ years’ experience in related field, preferred

Responsibilities

Coordinate and manage QRA-related activities throughout the facility by:
Investigate non-conformances with QRA policies and report to Corp QRA, vendors, business partners and other leadership groups, as necessary (FDA)
Document the event utilizing the current NCR/CAPA system
Investigate, coordinate investigation, or follow-up for closure of customer complaints and provide response to Corp QRA or another designated group.
Oversee compliance with established procedures
Function as the facility POC for agency or internal QRA inspections
Oversee facility training programs (FDA, DOT, etc.) and work with local trainers to ensure training completions
Assist with licensure requests to include research on regulations, providing sales reports, or answering general license questions
Quality support required for the Velocare (hospital in home) program
May be responsible for the quality process at multiple facilities.
Facilitate temperature monitoring for all assigned storage locations as required by procedure
Review and authorize monthly temperature records to ensure completion and accuracy
Coordinate calibration of temperature monitoring equipment; maintain and verify appropriate records are maintained.
Draft, implement and conduct training on the facility plans Temperature Contingency Plan, Site Security Plan
Facilitate reporting and management of temperature excursions and other situations involving execution to Contingency or Security plans.
Ensure that quarterly reviews of badge access, master key disbursement and after-hours access reports are completed by the facility Security Coordinator.
Coordinate annual security alarm tests and quarterly alarm tests for refrigerators and freezers (and if necessary warehouse areas, as directed by Corp QRA).
Ensure documentation is complete and filed accordingly.
Oversee or coordinate the facility on-call list.
Manage or coordinate any changes/updates with local Security company.
Ensure that facility alarm system is adequately set for emergency doors and after-hours conditions
Coordinate with on-site Facilities team (if applicable) preventative maintenance activities for all equipment utilized at the facility HVAC Refrigerator (as applicable) Freezer (as applicable) Dock doors and plates Generator Roof Water heaters Other equipment as defined by QRA policy
Coordinate with on-site team to develop and maintain a listing of equipment and systems that require a preventative maintenance program.
Conduct facility temperature studies as required to maintain compliance to applicable regulations (NABP, BoPh)
Oversee facility process to ensure product is maintained and stored according to required storage requirements, including temperature, protect from light, upright storage, cube, debris, out of location product, etc.
Coordinate with appropriate facility personnel non-compliant with storage requirements
Develop and implement a corrective action plan to prevent recurrence.
Ensure that the facility does not ship expired product
Periodically verify that expired product is appropriately tagged and moved into quarantine areas as soon as possible after discovery
Ensure there are designated product storage areas for all product status types (FCA, Quarantine, Hold, Discard, etc.).
Facilitate and/or organize facility housekeeping program. Dust protection Sterile barrier inspections Contamination of ValueLink totes
Facilitate pest control program at facility. Ensure monthly checks are complete and according to protocol and that required maintenance noted on monthly reports is addressed.
Facility POC for training program (or co-facilitator with local training coordinator)
Maintain or coordinate with local training coordinator employee training files (myLearning)
Complete or coordinate all required QRA training for facility employees on all QRA policies PDMA, temperature, site security, LUM, Good Documentation practices, storage Returns, FCA, hazmat, etc. Other training (FOBs, policy updates, special projects, as required)
Ensure that a facility’s hazardous materials program meets current policy
Ensure that hazardous materials are stored in appropriate locations in warehouse
Coordinate with Outbound Operations shipments of hazardous materials are being prepared correctly according to current policy
Verify that all appropriate packaging supplies are available as dictated by policy for hazardous materials shipments
Ensure that the facility’s cold-chain packing program meets current policy.
Verify that all appropriate packaging supplies are available as dictated by policy for refrigerated or frozen product shipments.
Monitor and verify site compliance with specified FCA, returns, and other QIC-related programs to ensure that on-site process meets QRA policy)
Verify (spot-check) documentation to determine compliance with Good Documentation Practices (GDP), current policy and that the packet of information is available and complete
Verify site compliance with any stipulated DSCSA and vendor verification requirements

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs