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MV01-032423 Specialist QA (Non-standard shift)

MV01-032423 Specialist QA (Non-standard shift)

Validation & Engineering GroupGuaynabo, PR, US
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Specialist QA (Non Standard 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 :

  • 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

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    Qa Specialist • Guaynabo, PR, US

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