Investigations Specialist
Hospira 233 reviews - Clayton, NC

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Hospira is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees.

The Hospira Clayton operation has over 300 employees and manufactures generic injectable drug products and devices. The drug products comprise of emulsion and solution products in both the small volume and large volume glass container configurations. All products manufactured at the Clayton operation are terminally sterilized.

The Hospira Clayton operation has an opening for an Investigations Specialist.

This individual is responsible for ensuring timely review of drafted investigations are performed with the proper documented evidence of root cause and Corrective and Preventative Actions. This individual will work closely with employees at multiple levels within the organization in order to achieve timely approval of investigations. The individual will be expected to actively participate in weekly Investigation Review Board (IRB) meetings and work closely with the Quality Management group to ensure timely closure of investigations. Additionally, this individual will be responsible for timely completion of “high” compliance risk investigations based on assignment by Quality Management.

MAJOR DUTIES AND RESPONSIBILITIES: · Assist with development of an investigational plan for newly created events.
· Participate in the investigation teams created to determine root cause of exception reports.
· Perform the peer review of draft investigations of Investigation writers.
· Actively investigate assigned “high” compliance risk investigations.
· Serve as the liaison between quality, operations, and regulatory for investigation.
· Achieve qualification for the approval of “low” level classified events.
Skills/Experience Education/Certification
· Bachelor's degree required; Master’s degree preferred.
· 4 - 6 years experience in Quality, Manufacturing, Engineering or R&D functions, or any combination.
· Extensive knowledge of root cause analysis.
· Proven experience with the timely completion of all classification levels of investigations.
· Working knowledge of foreign and domestic regulatory guidelines.
· Must have a working knowledge of Quality tools.
· Superior technical writing and problem solving skills.
· Strong administrative and organizational skills are required.
· Strong oral and written communication skills, strong interpersonal and adept at communication with employees at multiple levels within the organization.

About this company
233 reviews
Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...