Quality Manager
PharMEDiumServices, LLC, an AmerisourceBergen Company, is a growing outsource compoundingorganization servicing hospitals nationwide.
If you arefrom the pharma industry or medical device industry with aseptic experience, wewant to meet you!
TheQuality Manager will lead a staff of Supervisors and Technicians that performdaily quality assurance activities and functions,. The Quality Manager willensure that staff performs routine tasks in a timely manner according toestablished Standard Operating Procedures through direct observation andreview.
Responsibilities:
1.The Quality Manager will assist the Directorof Quality Operations in assuring that PharMEDium's core values are continuallyemphasized and kept in the forefront of facility operations.
2.Will be responsible for the daily flow ofdocumentation through the facility, will ensure that all documentation non-conformance are investigated and corrective actions are developed andimplemented in a timely and efficient manner.
3.Will ensure, through continuous monitoring andauditing, all processes downstream and upstream of the clean room operation areconforming to PharMEDium approved policies and procedures. This effort will becoordinated with the Facility Operations Manager.
4.Ensures compliance to procedures, governingregulations and address non-compliance issues.
5.The Quality Manager will set the tone forquality processes and services to deliver safe compounded preparations tohospital customers.
6.Will conduct internal audits of processes,systems and procedures.
7.Participate in cross-functional teams toidentify effective corrective and preventive actions to improve Lean processquality.
8.Working with the Director of QualityOperations will assure timely closure of audit items.
9.Will initiate SOP revisions as needed toassure compliance, continuous improvement of overall operation.
10.Drive the collection and compilation of datafor submission of all DEA related reports which include ARCOS reports,Procurement Quota Requests and Year End Reports.
11.Conduct root cause analysis for area ofresponsibility at the facility during all phases of the Center processes.
12.Ensure all Quality related documentsgenerated at the Facility are received into the Documentation Center at theappropriate time per procedure.
13.Perform review of Quality related documentsgenerated at the Facility.
Bachelor's Degree in Science or relatedfield desired.
2.Minimum of 5-7 years' experience in Quality, or related field in thehealthcare industry.
3.Demonstrated understanding of quality assurance in a regulated (FDA, DEA,ISO) environment.
4.Thorough understanding of the Governmental requirements in a sterileprocessing environment.
5.Computer skills in word processing, spreadsheets and databases required.
6.Effective problem solving, supervisory, strong communication (written andverbal) and organizational skills.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
If you arefrom the pharma industry or medical device industry with aseptic experience, wewant to meet you!
TheQuality Manager will lead a staff of Supervisors and Technicians that performdaily quality assurance activities and functions,. The Quality Manager willensure that staff performs routine tasks in a timely manner according toestablished Standard Operating Procedures through direct observation andreview.
Responsibilities:
1.The Quality Manager will assist the Directorof Quality Operations in assuring that PharMEDium's core values are continuallyemphasized and kept in the forefront of facility operations.
2.Will be responsible for the daily flow ofdocumentation through the facility, will ensure that all documentation non-conformance are investigated and corrective actions are developed andimplemented in a timely and efficient manner.
3.Will ensure, through continuous monitoring andauditing, all processes downstream and upstream of the clean room operation areconforming to PharMEDium approved policies and procedures. This effort will becoordinated with the Facility Operations Manager.
4.Ensures compliance to procedures, governingregulations and address non-compliance issues.
5.The Quality Manager will set the tone forquality processes and services to deliver safe compounded preparations tohospital customers.
6.Will conduct internal audits of processes,systems and procedures.
7.Participate in cross-functional teams toidentify effective corrective and preventive actions to improve Lean processquality.
8.Working with the Director of QualityOperations will assure timely closure of audit items.
9.Will initiate SOP revisions as needed toassure compliance, continuous improvement of overall operation.
10.Drive the collection and compilation of datafor submission of all DEA related reports which include ARCOS reports,Procurement Quota Requests and Year End Reports.
11.Conduct root cause analysis for area ofresponsibility at the facility during all phases of the Center processes.
12.Ensure all Quality related documentsgenerated at the Facility are received into the Documentation Center at theappropriate time per procedure.
13.Perform review of Quality related documentsgenerated at the Facility.
Bachelor's Degree in Science or relatedfield desired.
2.Minimum of 5-7 years' experience in Quality, or related field in thehealthcare industry.
3.Demonstrated understanding of quality assurance in a regulated (FDA, DEA,ISO) environment.
4.Thorough understanding of the Governmental requirements in a sterileprocessing environment.
5.Computer skills in word processing, spreadsheets and databases required.
6.Effective problem solving, supervisory, strong communication (written andverbal) and organizational skills.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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