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

Shift: Administrative 
 

Location: Vega Baja, PR 

Education: Bachelor's degree and 5 years of directly related experience
 

Skills:

• 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.

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 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

Affiliated Companies

Affiliated Companies: Echo Consulting Group Inc