Oversees the development, implementation, and maintenance of quality assurance activities. Oversees generation and review of documents used in good manufacturing practices. Monitors internal compliance audits of Production, Warehouse, Maintenance and Quality Control areas. May audit raw material vendors and prepare manufacturing documentation for updated filing. Coordinates interdepartmental activities related to enhancement of cGMP knowledge and understanding. Coordinates reporting and maintenance of CAPA process. May lead investigations and resolve potential product quality issues to improve efficiency. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
· Conduct effectiveness assessments of corrective and preventive actions. Prepare monthly and quarterly CAPA reviews as applicable.
· Assist Quality Assurance Director in preparation for and participate in inspections and cGMP audits.
· Ensure the internal and supplier audit schedule is completed on schedule.
· Manage subordinate schedules as appropriate to assure time-lines and schedules are met.
· Oversee Document Control for cGMP documents including training records and document retention. Establish and administer GMP training programs.
· Oversee data compilation for Annual Product Review process.
· Ability to perform at or above established quality and productivity standards.
· Training of new-hires in areas of Key Responsibilities.
· Perform additional duties as assigned by management; job duties may vary by location.
· Regular attendance is an essential function of the job.
· Follow all applicable government regulations including HIPAA, FDA, OSHA, and EPA.Required Qualifications(must be met in order to perform the job at the required level)
Day Shift Monday-Friday.
· B.S. Degree or Associates Degree with 5 years experience in Quality Assurance/Regulatory/Quality Control in an FDA Regulated industry.
· Proficient in MS Office applications
· Excellent oral and written communication skills
· 3+ years supervisory experience
· Display behavior which exemplifies employee code of conduct guidelines and Omnicare Core Values.
Preferred Qualifications(if above and beyond the minimum required)
· 5 years in Pharmaceutical Quality Assurance/Regulatory/Quality
· Formal cGMP training and equivalent experience in regulated industry
B.S Degree of Associates Degree with 5 years experience in Quality Assurance/Regulatory/Quality Control in an FDA Regulated industry.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 EEO AA CVS Health
CVS Health does not require nor expect that applicants disclose their compensation history during the application, interview, and hiring process.
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/