Microbiology Manager - GMP
Location:
Northbrook , Illinois
Posted:
May 30, 2017
Reference:
512997BR
Position Summary:
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 this role, you will have ownership for the development of a brand new Microbiology laboratory that will support 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 the Microbiology Manager, you will demonstrate a high level of expertise in the practice of cGMP environmental monitoring in sterile manufacturing. In addition, you will assist with development of other SOPs related to clean room controls and processes, assuring cGMPs and company policies and procedures are followed and updated. You will be accountable for meeting functional area goals and objectives as they relate to departmental and company goals, while adhering to cGMP regulations, USP standards, and company policies.

Key responsibilities:

  • Oversee the viable and non-viable environmental monitoring throughout multiple facilities, according to established Policy and Procedures.
  • Develop and manage all Processes and Policy and Procedures relevant to microbiology department. Including but not limited to: Data management, LIMS implementation, Trending Results, Equipment Setup and Validation, ID technology procurement, etc.
  • Properly incubate and examine samples for microbial growth.Perform Gram stain as required and ID
  • Complete all documentation properly according to cGMP requirements. Assess the limits compared to the results to determine if an excursion within the environment has occurred.
  • Oversee data entry and trending of EM results into established data base. Create trending mechanism for all data and develop alert limits based upon historical data.
  • Perform routing laboratory duties which may include environmental monitoring which may include media growth promotion and handling,autoclave operation, testing equipment maintenance, cleaning of laminar flow hoods, proper disposal of samples, etc.
  • Assist with studies and investigations as needed. Complete additional sampling in response to investigative requirements.
  • Maintain effectiveness of the Quality System components relevant to this position.
  • Manage and oversee a team of direct reports.
  • Create training material to train staff on proper aseptic technique and sample collection.
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


Required Qualifications:
  • Minimum 4 years of experience in cGMP Quality System function in the pharmaceutical or biotechnology industry.
  • Minimum 2 years supervisory/management experience.
  • Minimum one year experience working in Microsoft Office, specifically Excel, Outlook and Word.
  • Requires experience managing environmental programs.
  • Requires ability to deal appropriately with regulatory agencies.
  • Requires detailed knowledge of cGMP and USP and regulations and standards.


Preferred Qualifications:
  • Home Infusion experience


Education:
Bachelor’s degree in Microbiology.





Business Overview:
Coram CVS/specialty infusion services is a leading national provider of specialty home infusion and specialty pharmacy services. The integration of Coram into CVS Health enables the company to offer enhanced, comprehensive infusion services; expanded payer access; and a national network of more than 85 locations, including 65 ambulatory infusion suites. Providing infusion therapies and services to over 20,000 patients each month, Coram cares for patients through all phases of their healthcare continuum including clinical and compliance monitoring, and individual patient counseling. CVS Health, through our unmatched breadth of service offerings, is the nation’s largest pharmacy health care provider transforming the delivery of health care services in the U.S. Our energetic and service-oriented colleagues embrace fresh ideas, new perspectives, a diversity of experiences, and a dedication to service to meet the needs of the many people and businesses relying on us each day.



















CVS Health is an equal opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, ethnicity, ancestry, color, religion, sex/gender (including pregnancy), national origin, sexual orientation, gender identity or expression, physical or mental disability, medical condition, age, veteran status, military status, marital status, genetic information, citizenship status, unemployment status, political affiliation, or on any other basis or characteristic prohibited by applicable federal, state or local law. CVS Health will not discharge or in any other manner discriminate against any Colleague or applicant for employment because such Colleague or applicant has inquired about, discussed, or disclosed the compensation of the Colleague or applicant or another Colleague or applicant. Furthermore, we comply with the laws and regulations set forth in the following EEO is the Law Poster:



EEO IS THE LAW















Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. If you require assistance to apply for this job, please contact us by clicking



AA EEO CVS Health















For inquiries related to the application process or technical issues please contact the Kenexa Helpdesk at 1-855-338-5609. For technical issues with the Virtual Job Tryout assessment, contact the Shaker Help Desk at 1-877-987-5352. Please note that we only accept resumes via our corporate website: https://jobs.cvshealth.com/

A little about us:

Please stay connected with us: Sign up to receive our job alert notifications.

Or learn more about us: https://jobs.cvshealth.com/careers-news

Know someone who would be interested in this job? Share it with your network.