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 (Non Standard shift)

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

Competence/Skills:

• Perform sampling plans for all manufactured products.
• Perform batch record review.
• Perform SAP transactions.
• Perform Trackwise system queries, deviations.
• Participate in triage process.
• Perform oversight of the process and procedures/GMP task.
• Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies.
• Participate in internal plant audits.
• Work with operations to resolve basic compliance discrepancies.
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Microsoft Office spreadsheet and application skills and presentation knowledge.
• Validated skill in working independently and to optimally interact with all levels throughout the organization.
• 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.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.

Shift: Non-standard shift 5:00 pm – 5:30 am