Specialist QA (5:00 pm - 5:30 am)

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Specialist QA for their Juncos, Puerto Rico location. The candidate will execute quality oversight, ensuring compliance with Good Manufacturing Practices (cGMP) in pharmaceutical operations. Responsibilities include evaluating process validations, executing quality dispositions, leading investigations, and collaborating with cross-functional teams to enhance quality management. Candidates should have relevant academic qualifications and experience in QA practices, with bilingual proficiency in English and Spanish being an advantage.

Qualifications

• Doctorate, Masters + 2 years, or Bachelors + 4 years in a related field required.
• Expertise in validation of GxP applications and Quality Assurance practices.
• Bilingual proficiency in English and Spanish preferred.

Responsibilities

• Execute approval/rejection of bulk drug substances.
• Ensure compliance with cGMP and cGLP standards.
• Support internal/external audits and inspections.
• Champion continuous improvement initiatives.

Skills

Experience with documentation platforms (CDOCS)

Experience in computer systems validation (CSV)

Knowledge of manufacturing and distribution processes

Strong organizational skills

Strong communication skills

Education

Doctorate

Masters + 2 years of experience

Bachelors + 4 years of experience

Tools

SAP

Maximo

TrackWise

LIMS

Job description

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

Specialist QA (5:00 pm – 5:30 am)

Summary

Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.

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

• Doctorate
• Masters + 2 years of directly related experience
• Bachelors + 4 years of directly related experience

Responsibilities

• Execute quality disposition (approval or rejection) of bulk drug substances.
• Provide quality oversight to ensure that operations for clinical and licensed pharmaceutical drug substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
• Ensure that deviations from established procedures are identified, reported, and documented per procedures.
• Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
• Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
• Ensure completion of required training and maintain assigned training adherence to support successful task execution.
• Collaborate and partner cross‑functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
• Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
• Alert senior management of quality, compliance, supply, and safety risks.
• Provide support and oversight for New Product Introduction (NPI).

Attributes

• Experience with key electronic systems such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
• Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• Strong organizational skills, with the ability to drive assignments through successful completion.
• Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.

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.