PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
If you are from the pharma industry or medical device industry with aseptic experience, we want to meet you!
The Quality Manager will lead a staff of Supervisors and Technicians that perform daily quality assurance activities and functions,. The Quality Manager will ensure that staff performs routine tasks in a timely manner according to established Standard Operating Procedures through direct observation and review.
1.The Quality Manager will assist the Director of Quality Operations in assuring that PharMEDium's core values are continually emphasized and kept in the forefront of facility operations.
2.Will be responsible for the daily flow of documentation through the facility, will ensure that all documentation non-conformance are investigated and corrective actions are developed and implemented in a timely and efficient manner.
3.Will ensure, through continuous monitoring and auditing, all processes downstream and upstream of the clean room operation are conforming to PharMEDium approved policies and procedures. This effort will be coordinated with the Facility Operations Manager.
4.Ensures compliance to procedures, governing regulations and address non-compliance issues.
5.The Quality Manager will set the tone for quality processes and services to deliver safe compounded preparations to hospital customers.
6.Will conduct internal audits of processes, systems and procedures.
7.Participate in cross-functional teams to identify effective corrective and preventive actions to improve Lean process quality.
8.Working with the Director of Quality Operations will assure timely closure of audit items.
9.Will initiate SOP revisions as needed to assure compliance, continuous improvement of overall operation.
10.Drive the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports.
11.Conduct root cause analysis for area of responsibility at the facility during all phases of the Center processes.
12.Ensure all Quality related documents generated at the Facility are received into the Documentation Center at the appropriate time per procedure.
13.Perform review of Quality related documents generated at the Facility.
Bachelor's Degree in Science or related field desired.
2.Minimum of 5-7 years' experience in Quality, or related field in the healthcare industry.
3.Demonstrated understanding of quality assurance in a regulated (FDA, DEA, ISO) environment.
4.Thorough understanding of the Governmental requirements in a sterile processing environment.
5.Computer skills in word processing, spreadsheets and databases required.
6.Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills.
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