QA Specialist: Validation, CAPA & Change Controls

Veg Group; Puerto Rico; On-site; USD 85,000 - 125,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Specialist QA to support its Quality Assurance program under minimal supervision in the pharmaceutical/biotech space.

The role involves reviewing and approving MPs, validation protocols, incident triage, deviations, CAPAs, and change controls, with cross-functional collaboration across Manufacturing, Engineering, and Process Development.

Qualifications

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years or Associates + 8 years or High school/GED + 10 years of directly related experience.
• GMP manufacturing experience in QA, including review/approval of change controls, deviations, CAPAs, protocols, reports and procedures.
• Strong organizational skills and ability to lead cross functional teams.
• Bilingual English/Spanish communication preferred.
• Ability to interact with regulatory agencies and to document/present clearly.

Responsibilities

• Review and approve product MPs.
• Approve validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Release sanitary utility systems.
• Approve planned incidents.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• 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.

Skills

GMP experience

QA documentation

Cross-functional leadership

Regulatory interaction

Bilingual English/Spanish

Strong communication

Education

Doctorate or Masters + 2 years related experience

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Specialist QA to support its Quality Assurance program under minimal supervision in the pharmaceutical/biotech space.

The role involves reviewing and approving MPs, validation protocols, incident triage, deviations, CAPAs, and change controls, with cross-functional collaboration across Manufacturing, Engineering, and Process Development.