Quality Assurance Manager - Microbiology
Providence , Rhode Island
April 04, 2017
We are starting up a new Microbiology Laboratory with CVS Health! This is a great opportunity to utilize your Microbiology and management experiences to create a new program from the ground up. In the Quality Assurance Manager role, you will develop a QA program and build a team supporting multiple facilities across the country producing aseptically-produced sterile compounds. Your team will monitor a national operation providing specialty home infusion care to over 40,000 patients per month! Read more details about this opportunity below:

As a Quality Assurance Manager, you will be responsible for the development and management of quality systems for multiple facilities preparing aseptically-produced sterile compounds. Initial responsibility will be to develop and manage an investigation program (RCA) and CAPA monitoring and tracking program. Responsibilities will broaden to include equipment maintenance/calibration tracking, risk assessment/FMEA development for current/proposed processes.

Key responsibilities:
* Develop and manage a root cause analysis (RCA) program, CAPA program and CAPA effectiveness monitoring program.
* Create central database that allows the tracking and trending of OOL, Investigations and CAPAs.
* Analyze data to identify process improvement.
* Create and manage the FMEA and/or risk assessments program to ensure evaluation of processes, equipment and facility design.
* Create gap analysis tools which ensure facilities and processes are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
* Develop change control policy and processes which includes pre-approving and approving of change controls.
* Develop and manage equipment qualification, maintenance and calibration program.
* Participates in quality projects and teams to implement improvements to processes, facilities and equipment.
* Provides training to appropriate personnel related to facilities and equipment quality system.

Coram CVS/specialty infusion services is a Fortune 7 company and national leader in the home infusion and enteral fields. This is uniquely rewarding opportunity putting your skills and experiences to work supporting an innovative specialty pharmacy operation.

Learn more about us: https://www.youtube.com/user/CoramHealthcare or https://www.youtube.com/user/CVSPharmacyVideos

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