QA Technical Specialist

Cencora•Puerto Rico, TX

17h•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 QA Technical specialist has a key role considering that this role is supporting the site Change Management operation. Responsibilities: This role is responsible for review and audit of validation/ qualification /verification activities including but not limited to manufacturing, packaging, utilities, facilities, laboratories, and systems. Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites and changes to site products including the Regulatory Impact Assessment (evaluation of markets requirements and contact with Regulatory principals above site). Review and approve Operational Qualification and Performance /Process Qualification and Verification and SOP associated to these processes. In addition, this role Review and approve analytical test methods validation/verification reports, specifications, tests methods, laboratory instruments qualifications, periodic review, Risk Assessments, Commissioning Documentation, Installation Certification and Master Batch Records which includes manufacturing and packaging. Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing out completed CR. Reviews proposed changes documentation, perform the assessment of the regulatory impact of proposed changes and assures completeness of required documents prior to approval. Supports the PCF sponsors in the preparation of change requests by providing needed regulatory documents. Creation and revision of Export profiles of assigned products. Support all activities of new R&D Products including change controls, development and validation documentation among others Support APR contributions process Review documentation and CC related to shipping labels and artwork 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 Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health. Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines. 1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy. 2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on Cencora.com/careers 3.) Guard Your Personal Information: Only share sensitive information after vetting the employer’s credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application. 4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process. 5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in @cencora.com, @alliance-healthcare.net, @alliance-healthcare.co.uk, alliance-healthcare.fr or alliance-healthcare.ro Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes. If you believe you have encountered a job scam posing as a Cencora opportunity, please report it immediately to: [email protected]

Requirements

Bachelor's degree and 5 years of directly related experience
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Values/Leadership Practices.

Responsibilities

This role is responsible for review and audit of validation/ qualification /verification activities including but not limited to manufacturing, packaging, utilities, facilities, laboratories, and systems.
Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites and changes to site products including the Regulatory Impact Assessment (evaluation of markets requirements and contact with Regulatory principals above site).
Review and approve Operational Qualification and Performance /Process Qualification and Verification and SOP associated to these processes.
Review and approve analytical test methods validation/verification reports, specifications, tests methods, laboratory instruments qualifications, periodic review, Risk Assessments, Commissioning Documentation, Installation Certification and Master Batch Records which includes manufacturing and packaging.
Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing out completed CR.
Reviews proposed changes documentation, perform the assessment of the regulatory impact of proposed changes and assures completeness of required documents prior to approval.
Supports the PCF sponsors in the preparation of change requests by providing needed regulatory documents.
Creation and revision of Export profiles of assigned products.
Support all activities of new R&D Products including change controls, development and validation documentation among others
Support APR contributions process
Review documentation and CC related to shipping labels and artwork