Specialist QA

Veg Group; Carolina (PR); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program with minimal supervision at our facility. You will review and approve MPs, validation protocols, and incident triage decisions, and own QA procedures on site.

The role requires strong knowledge of GMP, GDP, and electronic quality systems, with bilingual English/Spanish preferred. Collaboration with Manufacturing, Engineering, and Process Development is essential, including weekend or

Qualifikationen

• Advanced degree with QA experience in GMP environments.
• Experience reviewing change controls, deviations, CAPAs, protocols, reports, and procedures.
• Bilingual English/Spanish communication preferred.
• Strong organizational and cross-functional leadership skills.
• Ability to interact with regulatory agencies.
• Independent work style with effective communication.

Aufgaben

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and ensure corrective actions.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Support automation, facilities and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls and disposition of lots for shipment.

Kenntnisse

GMP knowledge

QA review

Deviation handling

Process validation

Investigations

Regulatory interaction

Bilingual EN/ES

Ausbildung

Doctorate or Masters + 2 years of related experience

Bachelor + 4 years of related experience

Associates + 8 years of related experience

High school/GED + 10 years of related experience

Tools

Electronic quality systems

Jobbeschreibung

Current job opportunities are posted here as they become available.

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:

• Specialist QA

Description:

Perform one or more of the following duties and responsibilities in support of the 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.
• Release of 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.

Qualifications:

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.
• Preferred candidates will have GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired. Bilingual English/Spanish communication skills are preferred.
• 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.
• Available to work extended hours, possibility of weekends and holidays.