Specialist, Quality Operations

Safecor Health•Columbus, OH

3d•Onsite

About The Position

The Quality Specialist supports quality operations at Safecor Health by adding and updating drugs in the system; creating and revising labels for all business segments; and participating in quality reviews of designated service segments and supporting processes. The role supports standard processes, helps ensure compliance with applicable standards, works with operations staff to implement and maintain inspection procedures, and assists in developing standards that meet quality specifications. It also provides quality oversight during production. The position participates in controlled-substance inventory management and documentation, as well as quality assurance activities such as audits, deviation and incident investigations, and training. Responsibilities also include incoming and in-process inspections, final quality checks, documentation management, and communication of inspection findings to management and peers.

Requirements

Bachelor’s degree in a science-related discipline.
Three years of experience in the pharmaceutical industry.
Quality experience within an FDA facility.
Experience and knowledge of medication repackaging.
General knowledge of medications and controlled-substance regulations.
Ability to prepare training materials and present to small groups.
Ability to read, speak, and write in English.
Self-directed, with strong attention to detail and good organizational skills.
Ability to work collaboratively across groups to support business goals.
Ability to manage competing priorities as business and employee needs evolve.
Familiarity with SharePoint and Microsoft applications, including Word, Excel, and PowerPoint.
Excellent attendance and reliability.
Strong verbal and written communication and collaboration skills.
Ability to develop and maintain positive relationships with employees, officials, regulatory agencies, and other stakeholders.
Demonstrated emotional intelligence and self-awareness, credibility, self-determination, ownership, and urgency.
Curiosity, adaptability, willingness to share knowledge, and ability to contribute to an inclusive environment that welcomes feedback, ideas, and perspectives.
Specific vision abilities, including close, distance, color vision, and depth perception, with or without corrective devices or supports.
Ability to lift up to 30 pounds as needed.

Responsibilities

Enter and track training records in the Quality Learning Management System.
Maintain supplier lists.
Create and manage labels for all Safecor Health business segments.
Facilitate end-of-day documentation filing and QAD updates.
Track and document controlled-substance samples and manage DEA 222 forms.
Manage the ARCOS quarterly report.
Participate with Operations in investigating and writing unplanned deviations and incident reports.
Execute assigned quality audits, assemble data, and write reports.
Participate in incoming inspections of repackaging components or drugs.
Perform final quality checks for designated repackaging formats.
Communicate with customers in a timely and concise manner.
Perform in-process quality checks and final inspections on commercial lots.
Complete daily and monthly control-retain-sample audits.
Help facilitate quarterly, year-end, and ad hoc destruction of prescription and over-the-counter drugs.
Contact drug manufacturers to obtain drug-related information.
Inspect finished products, supplies, equipment, personnel, and facilities for adherence to quality specifications and current Good Manufacturing Practices.
Communicate out-of-specification results and inspection findings effectively and thoroughly to management and peers.
Work with operations staff to ensure inspection procedures are implemented and maintained.
Assist in developing standards to meet quality specifications and provide quality oversight during production.
Participate in quality assurance activities, including facilitating audits, deviations, incident reports, and training.