The Role
Support plant Quality Assurance across manufacturing, process validation, regulatory compliance, and quality systems. Responsibilities include reviewing batch records and manufacturing documentation, leading deviations, CAPAs, investigations, audits, change controls, risk assessments, and validation activities. The role supports new product introduction, commissioning and qualification, environmental and facilities programs, lot disposition, and regulatory inspections while collaborating with manufacturing, QC, engineering, and other cross-functional teams. Bilingual English and Spanish communication is required.
Summary Generated by Built In
Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Non-Standard Shift (12 working hours)
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.
Requirements & Qualifications:
- Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
- Actively engage in continuous improvement initiatives, programs, and projects.
- Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
- Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
- Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
- Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
- Accountable for adherence to assigned training, permitting execution of required tasks.
- Champion continuous improvement initiatives and projects.
- Provide support and oversight for New Product Introduction (NPI).
- Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
- Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
- Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
- Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
- Validated experience serving as Quality Contact for complex projects involving new products.
- Validated experience in commissioning and qualification.
- Strong organizational skills, including the ability to follow assignments through to completion.
- Enhanced skills in leading, influencing, and negotiating.
- Demonstrate the ability to interact effectively with regulatory agencies.
- Solid word processing, presentation, database, and spreadsheet application skills.
- Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
Functions:
- 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
Education
- Bachelor's in science or engineering+ 4 years of directly related experience
Skills Required
- Bachelor's degree in science or engineering
- Four years of directly related experience
- Experience performing plant Quality Assurance review, approval, and tracking of cGMP manufacturing processes, procedures, testing methods, documents, and records
- Experience reviewing batch records and working with MES, EBR, SAP, EDMQ, DQMS, and TrackWise
- Validated expertise in deviations, CAPA, change control, and quality systems
- Experience with computer systems validation or computer systems quality assurance, particularly for medical devices
- Experience validating GxP applications, including Validation Master Plans, risk assessments, IQ, OQ, PQ, test scripts, and validation reports
- Experience with commissioning and qualification
- Experience supporting manufacturing, distribution, process development, quality control, and related QA processes
- Experience serving as a Quality Contact for complex new-product projects and supporting NPI
- Ability to lead investigations, audits, continuous improvement initiatives, and cross-functional projects
- Ability to interact effectively with regulatory agencies and support inspections
- Strong organizational, leadership, influencing, negotiation, communication, facilitation, and presentation skills
- Proficiency with word processing, presentation, database, and spreadsheet applications
- Fluency in written and spoken English and Spanish
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The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
