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
Description:
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Preferred:
Perform Trackwise system queries, deviations.
Participate in triage process.
Perform oversight of the process and procedures/GMP tasks.
Manage Change Controls and deviations for review and approval as QA contact.
Work with operations to resolve basic compliance discrepancies.
Knowledge in Validations and Laboratory area and equipment.
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.
Strong communication (both written and oral), facilitation and presentation skills.
Fully Bilingual in English and Spanish.
Validated skill in working independently and to optimally interact with all levels throughout the organization.
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:
Master's degree and 3 years of directly related experience.
Bachelor's degree and 5 years of directly related experience.
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.
