Quality Management System (QMS) SME

Pinnaql, Inc.; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Management System (QMS) SME to lead an end-to-end QMS review across GMP records, data integrity, and batch-release processes for FDA/EU-regulated environments.

The ideal candidate has 6+ years in pharmaceutical, biotechnology, or medical device manufacturing, is fully bilingual in English and Spanish, and is able to work on-site in Manatí, Puerto Rico. You will inventory records and system interfaces (ERP/MES/LIMS/eQMS), assess data integrity

Qualifications

• Bachelor's Degree in Engineering.
• Minimum of 6 years in pharmaceutical, medical device, or biotechnology industries.
• Experience in direct process/manufacturing areas.
• Fully bilingual English/Spanish with excellent oral skills.
• Proficient with MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated pharmaceutical, biologics, or medical-device manufacturing environments
• Demonstrated expertise in GMP records management, computerized system interfaces (ERP/MES/LIMS/eQMS), and materials traceability / lot genealogy
• Personnel with relevant regulatory and quality credentials and hands-on operational experience.
• Ability to work on-site at Manatí, Puerto Rico.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• End-to-End QMS Review: map end-to-end quality system from creation to archival.
• Review core QMS elements and interactions (deviation/CAPA, change control, document control, complaint handling, and product quality review).
• Assess alignment of current-state processes with the BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10).
• GMP Records & System Interfaces: inventory GMP records and systems (ERP/MRP, MES, LIMS, QMS/eQMS, WMS, and equipment/automation).
• Map interfaces and data hand-offs between systems, including manual transcription steps.
• Evaluate data integrity and ALCOA+ compliance across records and interfaces, including audit trails and review-by-exception practices.
• Identify single points of failure and gaps that could affect release package accuracy.
• Materials Traceability Review: assess end-to-end traceability from incoming inspection to finished goods; evaluate forward/backward traceability.
• Ensure lot genealogy, material status control, segregation, and reconciliation of quantities; recommend automated controls where needed.
• Batch Release Process Robustness: review batch record review and disposition workflow end-to-end; verify evidence for release decisions.
• Assess quality review of data supporting batch disposition, ensuring completeness, accuracy, and cross-checking before release.
• Benchmark against QMS standards and industry best practices; recommend enhancements for a robust release process.
• Gap Analysis, Recommendations, and Roadmap: document findings in a risk-ranked gap analysis; provide prioritized recommendations and an implementation roadmap.

Skills

Bilingual English/Spanish

QMS knowledge

Regulatory compliance understanding

Data integrity

Batch-release assessments

GMP records management

MS Windows

MS Office

Interfaces: ERP/MES/LIMS/eQMS

Materials traceability

Pharma/manufacturing experience

Education

Bachelor's Degree in Engineering

Tools

MS Windows

MS Office

ERP/MES/LIMS/eQMS interfaces

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Management System (QMS) SME

Description

End-to-End QMS Review

• Map the end-to-end quality system as it relates to GMP record creation, review, approval, and archival


• Review core QMS elements and their interactions, including deviation/CAPA management, change control, document control, complaint handling, and product quality review


• Assess alignment of current-state processes and procedures with the BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10 as relevant)

GMP Records and System Interfaces

• Inventory the GMP records (electronic and paper/hybrid) and the systems that generate, store, or consume them (e.g., ERP/MRP, MES, LIMS, QMS/eQMS, warehouse management, and equipment/automation systems)


• Map the interfaces and data hand-offs between these systems, including any manual transcription, reconciliation, or bridging steps


• Evaluate data integrity and ALCOA+ compliance across these records and interfaces, including audit trail adequacy and review-by-exception practices


• Identify single points of failure, redundant or conflicting records, and reconciliation gaps that could affect the completeness or accuracy of the release package

Materials Traceability Review

• Assess end-to-end traceability of materials: incoming inspection and acceptance, warehousing, dispensing/kitting, in-process consumption, component/subassembly linkage, packaging, and finished-goods


• Evaluate forward and backward traceability (i.e., the ability to trace any material to all finished lots, and any finished lot back to all constituent materials, equipment, and records)


• Review controls for lot genealogy, material status control, segregation, and reconciliation of quantities


• Identify where traceability relies on manual controls and recommend system-based or automated controls to close those gaps

Batch Release Process Robustness and Quality Data Review

• Review the batch record review and disposition workflow end to end, including the criteria and evidence relied upon for the release decision


• Assess the quality review of data supporting batch disposition — the completeness, accuracy, and integrity of the records and system data reviewed, and how they are verified, reconciled, and cross-checked prior to release


• Evaluate the adequacy, consistency, and defensibility of the review process, including review-by-exception practices and the handling of discrepancies, exceptions, and out-of-specification/atypical results


• Benchmark the process against the QMS Standard and industry good practice, and recommend enhancements to ensure a robust, right-first-time release process

Gap Analysis, Recommendations, and Roadmap

• Document all findings in a risk-ranked gap analysis, mapped to the relevant regulation and QMS Standard clause


• Provide prioritized recommendations distinguishing immediate/quick-win actions from medium- and long-term remediation


• Deliver an implementation roadmap with suggested sequencing, dependencies, and indicative effort/resource considerations
  

Qualifications

• Bachelor's Degree in Engineering.


• Minimum of 6 years of experience in direct pharmaceutical, medical device or biotechnology industries.


• Experience in direct process / manufacturing areas.


• Must be fully bilingual (English / Spanish) with excellent oral skills.


• Must be proficient using MS Windows and Microsoft Office applications.


• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.


• Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated pharmaceutical, biologics, or medical-device manufacturing environments


• Demonstrated expertise in GMP records management, computerized system interfaces (ERP/MES/LIMS/eQMS), and materials traceability / lot genealogy


• Personnel with relevant regulatory and quality credentials and hands-on operational experience.


• Ability to work on-site at Manatí, Puerto Rico.


• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.