Quality Manager- CAPA and Investigations
Quality Manager- CAPA and Investigations
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Job Description
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
The Quality Manager CAPA and Investigations is responsible for the management of the Quality Investigation team the Supplier Quality team and their daily activities which include Internal/External investigation CAPA and Deviation management Supplier quality and other activities as assigned. The Quality Manager will manage the processes for Internal and External investigation disposition of packaging components BPL drug product and contract packaging components; finished goods. The Quality Manager will also oversee the deviation process CAPA and Risk Management activities and conduct data analysis for tracking and trending purposes. In addition the Quality Manager will oversee the supplier quality process as it pertains to investigations auditing and quality agreements development.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division corporate and government regulatory requirements. It is the associates responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
- Directs leads trains and mentors the Quality Investigation and Supplier Quality teams.
- Provides direction of daily tasks and prioritizes workload of team.
- Utilizes process improvements by collecting and analyzing data to gain efficiencies while maintaining quality of work.
- Provide guidance to inspect release or reject quarantined packaging material and or finished drug products.
- Provides guidance to internal audit team and external audits of suppliers.
- Responsible for developing quarterly management reviews on investigation trending.
- Conducts performance reviews for direct reports.
- Develops and maintains departmental SOPs and Work Instructions in order to streamline processes.
- Responds to investigation CAPA and deviation queries from various functional areas
- Assures all associates follow cGMP and safety procedures
- Ability to develop and maintain cooperative working relationships
- Ability to handle a variety of tasks simultaneously
- Good verbal and written communication skills
- Performs related duties as assigned
Experience and Education:
A minimum of 3 years experience leading and directing the work of others required.
Requires a bachelors degree or equivalent combination of experience and education and four plus years directly related to the Pharmaceutical Industry.
Experience with Pharmaceutical Investigations Corrective and Preventive Action (CAPA) Deviation Management Root Cause Analysis tools cGMP documentation and Quality Assurance.
Knowledge of FDA regulations required.
Experience with a Document Control System (DCS) and Inventory management system required.
Skills and Abilities:
- Ability to lead and manage individuals
- Strong problemsolving and root cause analysis skills are required
- Proficient in Microsoft Office applications (Word Excel)
- Possess strong organizational skills for prioritizing workload and responsibilities
- Ability to handle multiple projects
- Must be able to work in a fastpaced environment and deliver projects and requests on time with respect to established timelines
What Cencora offers
We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every day. In addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more. For details visit time Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are nondiscriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returnedEqual Employment Opportunity
Affiliated Companies
Affiliated Companies: Amerisource Health Services LLC
Required Experience:
Manager
Employment Type
Full-Time
