MV03-030124 Specialist QA [12 hours shift]

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:

• Sr. Engineer
• 12 hrs. shift AM or PM, including weekends and Holidays.
  • The rotations runs Shifts A1 / A2 / B1 and B2.
  • A1 and B1 Day Shifts 5am-5:30pm
  • A2 and B2 Night Shifts 5pm-5:30am

Responsibilities:

• You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations.
• Actively engage in Continues Improvement initiatives, programs and projects
• Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
• Certify that deviations from established procedures are investigated and documented per procedures.
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
• Strategic advisor to senior management of quality, compliance, supply and safety risks.
• Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
• Accountable for assigned training adherence to permit execution of required tasks.
• Champion Continuous Improvement initiatives and projects.
• Provides support and oversight of New Product Introduction (NPI).
• Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control.
• Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency).
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products.

General Description:

• 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 or Associate's degree and 10 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.