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!
Summary of Role:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Responsibilities:
Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
Defines appropriate measures to ensure product quality.
Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
Reviews include applicable specifications, materials, tools, techniques, and methodologies.
Provides or directs verification and validation of software system requirements, traceability, and testability.
Shift: 1st and 2nd
Location: Juncos, PR
Education: Engineering degree: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming
Preferred Qualifications:
Automation/ Controls / Programming hands on experience
CAPA/ Investigations/ Root Cause Analyses/Technical Writing
Computer Software validations/GAMP knowledge – hands on experience
Knowledge in Medical Devices regulations
Years’ Experience Required: min.7 yrs on field (quality – excluding experience laboratory micro/chemistry ) or engineering or programming
Must have:
Experience with Risk management documentation: pFMEAs
Basic knowledge in PLC, general programming, Source Code Review
Basic knowledge in Root Cause Analysis
Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)
Engineering degree: Mechanical, Electric
al or Computer preferred
Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
Knowledge in Medical Devices regulations
Knowledge in GAMP
Skills:
Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager .
Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results .
May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
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 https://www.virtualfairhub.com/cencora
Full timeCencora 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 company’s 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 non-discriminatory.
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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned