Healthcare QA Supervisor - Helix Migration

Job Summary

This position communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. The incumbent will advise on development of Standard Operating Procedures (SOPs), reviews/approves client and facility work instructions, trains QA personnel, internal clients on SOPs/regulatory topics, and oversees the maintenance of the quality documents. This role participates in internal, client, agency audits, and follows up on audit outcomes. This position maintains knowledge of healthcare quality, regulatory requirements and assesses/addresses risks associated with the storage and distribution of healthcare products.

Responsibilities

• Monitors and instructs for compliance to UPS SCS site license requirements (DEL, MDEL, CDS, PCR)
• Promotes issue resolution, risk management, continuous improvements and project initiatives
• Facilitates, hosts, and respond to audits (internal, regulatory agencies and clients)
• Assists with creation, revision, and approval of controlled documents (SOP/WI/Forms)
• Provides investigation and non-conformance reporting, including development of proactive strategies for preventing recurrence
• Changes control management
• Provides quality compliance guidance to clients and internal staff
• Works as partners with our clients to communicate and adhere to regulatory guidelines
• Supports growth of new/expanded facilities, clients and services
• Participates in environmental control and CDS security emergency response action team
• Performs direct reports responsibilities (risk assessment, task delegation, performance evaluation, skills development, constructive feedback, formal performance review, formal career development)

Preferences

• Bachelor's Degree (or internationally comparable degree) in Science or related field

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law