Job Description

Job Description

Job Description

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 [Night Shift (5:00 PM to 5:30 AM 2-2-3)]

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

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

• 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.

Preferred:

• Fluent in English and Spanish, including writing.
• Strong English technical writing skills.
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
• Problem solving skills.
• Experience working with dynamic cross-functional teams and abilities in decision making.
• Strong organizational skills, including ability to follow assignments through to completion.
• Strong leadership capabilities and experience applying GMP requirements in an operational setting.
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

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