Commissioning & Qualification (C&Q) Specialist

Cencora•Aguadilla, PR

7h•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 consultant will deliver technical support for Commissioning, Qualification, and Validation (CQV). The CQV consultant is accountable for all CQV-related activities. This includes providing an update on the status of each document. The validation service will serve as the primary means to ensure that the schedule remains on track. The validation consultant should notify the project manager of any risks that could impact on the project plan and should provide support during project meetings. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. 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 https://www.virtualfairhub.com/cencora Full time Equal Employment Opportunity 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 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 [email protected] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Requirements

Bachelor’s degree in Engineering or a Scientific field.
Strong knowledge of cGMP/FDA regulations.
Ability to develop and adhere to self-directed standard work-organized and methodical with minimal guidance and be comfortable working as an individual and part of a team.
Exercises Good Judgment and Drives Change for Competitive Advantage.
Strong written and oral communication skills and ability to collaborate effectively with others.
Strong interpersonal, leadership and influencing Skills, communication and motivation.
Drives for Superior Results and Passion to Win with demonstrated record in getting things done.
Inspires Continuous Improvement

Nice To Haves

5+ years of experience in a regulated industry.

Responsibilities

Review CQV documents following standards and procedures
CQV Protocols development, execution coordination, execution, interpretation, approval, and report generation
Relocation activities
Develop CQV assessments
User Requirement development and approval
Functional Requirement & Design Specifications development and approval
Develop CQV Plan
Generate, review, get approval, and manage new SOPs and/or modify existing ones as required
Owns, generates, reviews, gets approval, and manages Change Controls as required
Performs validation assessments as part of the change control process and verify with the Change Owner and/or System Owner that there is no change control records in progress that could impact on the same validated system before the start of each validation exercise
Other CQV tasks may be assigned as needed.
A statistical consultant is requested for the design of experiments (DOE). This field of applied statistics focuses on the planning, execution, analysis, and interpretation of controlled tests. The aim is to evaluate the factors that influence the value of a parameter or group of parameters.