Validation & Engineering Group, Inc. (V&EG) 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

SUMMARY:

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

FUNCTIONS:

• Approve process validation protocols and reports for Quality Control and Information Systems.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Represent QA.
• 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 Deviation investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.
• Review and approve test run in Application Lifecycle Management (ALM).
• Review and approve Systems documents.

EDUCATION/LICENSES:

Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.

COMPETENCIES/SKILLS:

• Project management skills.
• 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.
• Available to work extended hours, possibility of weekends and holidays.
• Fully bilingual - English and Spanish