Quality Systems Spec

Cencora • Puerto Rico, TX

1d • Onsite

About The Position

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 Summary of Role: The majority of time is spent delivering the projects while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education

Requirements

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a University Degree and minimum of 2 years of relevant experience.
• Autonomy: Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of peer specialists; may manage projects / processes.
• Organizational Impact: Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Analysis provided is in depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
• Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product

Nice To Haves

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Process Validation and Computer software validation knowledge.
• Equipment Validations
• Manage Supplier Change Requests

Responsibilities

• Supports equipment and test method validation and supporting documentation as author or quality reviewer.
• Supports process documentation changes as author or quality reviewer.
• Provides oversight of quality processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides guidance in interpreting policies, regulatory regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Delivers projects assigned and works with other stakeholders to achieve desired results.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level