🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
Cookies & analytics consent
We serve candidates globally, so we only activate Google Tag Manager and other analytics after you opt in. This keeps us aligned with GDPR/UK DPA, ePrivacy, LGPD, and similar rules. Essential features still run without analytics cookies.
Read how we use data in our Privacy Policy and Terms of Service.
🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
PharmaLex • Juncos, Puerto Rico
Role & seniority: On-site, fixed-term contract Quality Assurance Lead/Specialist (designee for QA manager on local CCRB), with responsibilities enabling leadership in QA activities.
Stack/tools: QA/compliance workflows, validation protocols and reports (clean utilities, manufacturing processes, cleaning/ equipment, computerized systems), change controls, deviations, EMS/BMS alarms; strong MS Office (wording, presentations, databases, spreadsheets); data trending/evaluation; regulatory interaction.
Review and approve product MPs, process validation protocols/reports, EMS/BMS alarms, NC investigations and CAPA records.
Lead investigations and site audits; own site quality program procedures; release of sanitary utility systems and lots for shipment.
Represent QA on NPI team; designee for QA manager on local CCRB; review risk assessments and approve change controls.
Project management, strong organizational and cross-functional leadership capabilities.
Ability to interact with regulatory agencies; effective written/oral communication; independent work ethic.
Expertise in manufacturing QA/QAL, validation, process development, deviations, and change controls; advanced data trending/evaluation.
Experience in Quality and Compliance with validation protocols for clean utilities, manufacturing/cleaning processes, and computerized systems.
Background in biological processes.
Locati
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
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Responsibilities
Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Shift: Administrative 8-5pm
Location: Juncos, PR
Education
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Preferred Qualifications
Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc. Experience in biological processes desired.
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. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. 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