Sr Coordinator Quality Assurance Audit Omnicare

Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we deliver our services is just as important as what we deliver.
 
Our Heart At Work Behaviors™ support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable.

Position Summary
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, or coordinate and lead new product evaluations.
The position reports to the Director Vangard QA and works closely with Maintenance, Operations, Quality Control, Logistics, Customer Service, and CVS Corporate Compliance.

PRIMARY DUTIES AND RESPONSIBILITIES as assigned:
Validation Support
a. Write and execute validation documents as assigned.
b. Assist in executions as assigned.
New product implementation
a. Coordinate and oversee new product onboarding activities for specification creation.
b. Assure specifications approved and issued according to QA management approved attributes.
Environmental Monitoring
a. Perform environmental monitoring and trend reporting.
b. Perform incident investigations and assist in correction and preventative actions for out of specification environmental conditions.
Calibration
a. 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.
Licensing & Labeling

a. Create product labeling and submit FDA required labels.

b. Assist in federal and state licensing and regulatory applications.

Other duties as assigned.

Required Qualifications

Must be able to build effective working relationships with all colleagues, customers and business partners.
Display teamwork abilities and maintain a positive attitude.

Demonstrates ability to carry out assignments of a broad nature while exercising strong ability to manage multiple tasks with confidence.
Demonstrate excellent analytical, problem solving, and decision-making skills.
Demonstrate excellent interpersonal, written and oral communication skills.
Proficient in MS Office

Preferred Qualifications

PRIOR PREFERRED WORK EXPERIENCE:
1 to 5 years pharmaceutical experience as it relates to state and federal regulations and or education equivalent. Knowledge of FDA cGMPs

Education

High School Diploma

Pay Range

The typical pay range for this role is:

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls.  The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors.  
 
In addition to your compensation, enjoy the rewards of an organization that puts our heart into caring for our colleagues and our communities.  The Company offers a full range of medical, dental, and vision benefits.  Eligible employees may enroll in the Company’s 401(k) retirement savings plan, and an Employee Stock Purchase Plan is also available for eligible employees.  The Company provides a fully-paid term life insurance plan to eligible employees, and short-term and long term disability benefits. CVS Health also offers numerous well-being programs, education assistance, free development courses, a CVS store discount, and discount programs with participating partners.  As for time off, Company employees enjoy Paid Time Off (“PTO”) or vacation pay, as well as paid holidays throughout the calendar year. Number of paid holidays, sick time and other time off are provided consistent with relevant state law and Company policies.  
 
For more detailed information on available benefits, please visit jobs.CVSHealth.com/benefits

Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.

Salary : $19 - $32