Senior Coordinator Quality Assurance Audit
Location:
Glasgow , Kentucky
Posted:
December 13, 2017
Reference:
693020BR
Position Summary:

Omnicare,Inc. is a wholly owned subsidiary of CVS Health Corporation. www.cvshealth.com

Directly,and through our subsidiaries, Omnicare provides a broad array ofpharmacy-related services to long term care facilities and to other customersin the health care environment. While senior care has long been an Omnicarespecialty, we also serve other targeted populations.

Schedule: Varied 2nd or 3rd Shift

JobSummary:

Sr. Coordinator, QA supporting Solid Oral Dose Repackaging – These individuals play key roles in assurance that procedures and policies are implemented and executed for full FDA cGMP and DEA compliance. Individual may also manage a variety of projects.


Individuals may be assigned to perform annual process reviews, instrument calibrations, environmental monitoring, cGMP audits, analytical testing, to coordinate or execute DEA controlled substance procedures or coordinate and lead new product evaluations.


The position reports to the Manager, Vangard QA and works closely with Loss Prevention, Operations, Quality Control, Logistics, Customer Service, and CVS Corporate Compliance.

KeyResponsibilities:



1.DEA Compliance:


a.Generation and filing of ARCOS and State of FL reports.


b.DEA Audit Participant.


c.Maintain and complete 106s as necessary.


d.Plan and coordinate interdepartmentally to collect and account for destruction of controlled substance materials.


e.Plan and perform cycle counts and reconciliations.


f.Monitor and schedule expired and waste product for destruction.


g.Monitor waste trends and support Loss Prevention investigations on out of trend data.


2.New product implementation


a.Coordinate and oversee new product onboarding activities for specification creation.


b.Assure specifications approved and issued accouring to QA management approved attributes.


3.Environmental Monitoring

    1. Perform environmental monitoring and trend reporting.

b.Perform incident investigations and assist in correction and preventative actions for out of specification environmental conditions.


4.Calibration

    1. Manage calibration program to include procedure development, managing 3rd party calibrations, and performing instrument calibrations as assigned.

b.Perform incident investigations and assist in correction and preventative actions for out of specification environmental conditions.

  1. Training:
    1. Perform cGMP and SOP Trainings
    2. Issue and log training records within document management system.
    3. Make procedures current once training is complete.
  2. Perform internal audits (nonconformance or routine).Prepare and submit reports; coordinate and facilitate review meetings pertaining to audit findings.

7.Perform annual process review including process analysis, reporting and proposal of any needed actions.


8.Provide ideas for system improvement: streamlining of processes, additional controls, improved SOP’s.


9.Support of all performance management initiatives.


10.Responsible for maintenance of all state and federal government agency records


11.Ability to perform at or above established quality and productivity standards.


12.Perform other related duties, projects and analysis as assigned.



Required Qualifications:
High School Diploma












Preferred Qualifications:
1 to 5 years pharmaceutical/DEA experience as it relates to state and federal regulations

Quality Control Experience








Education:
High School Graduate


Business Overview:
CVS Health, through our unmatched breadth of service offerings, is transforming the delivery of health care services in the U.S. We are an innovative, fast-growing company guided by values that focus on teamwork, integrity and respect for our colleagues and customers. What are we looking for in our colleagues? We seek fresh ideas, new perspectives, a diversity of experiences, and a dedication to service that will help us better meet the needs of the many people and businesses that rely on us each day. As the nation’s largest pharmacy health care provider, we offer a wide range of exciting and fulfilling career opportunities across our three business units – MinuteClinic, pharmacy benefit management (PBM) and retail pharmacy. Our energetic and service-oriented colleagues work hard every day to make a positive difference in the lives of our customers.

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 consider qualified job candidates with criminal histories in a manner consistent with federal, state and local laws. 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 and EEO IS THE LAW SUPPLEMENT

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/

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