Documentation Associate? Batch Record Issuance

Documentation Associate? Batch Record Issuance

22 Jul 2024
California, Irvine, 92618 Irvine USA

Documentation Associate? Batch Record Issuance

Vacancy expired!




Stefanini Group is looking for a Document Control Associate - Batch Record Issuance in Irvine, CA that can start ASAP.



Shift: 1st shift (prefer 9-6 but flexible 8 hr shift between core hours of 6-6). There could be times of need for call backs during the weekend and weeknights for On-site support.

40-50 hrs per week



Position Summary

This position is responsible for the generation/issuance of master batch record documentation, fulfillment of internal/external requests and housekeeping of active/archived department documents to support internal and external business requirements.



Essential Duties & ResponsibilitiesGenerate, verify accuracy and issue master batch record documents including generation of LIMs record for drug product manufacturing and packaging based on the weekly production schedule, ensuring that all documentation required for each drug product batch is compiled prior to issuance to production for execution.Daily monitor and update QA-issued SOP Binders used throughout the manufacturing site when new effective SOPs are issued, and perform routine audits of all TPM SOP Binders throughout the site.Provide timely support and complete responses to QA documentation requests such as logbook issuance and reconciliation.Maintain document master batch record files and QA archives, so they are appropriately filed, labeled, stored and readily accessible.Maintain/update databases to ensure proper tracking of batch record issuancePerform other duties as assigned, or as business needs require.



Primary OutcomesCompletes accurate and timely review of all documentation listed above and ensures all Documentation is current, accurate and on schedule.Works on assignments that are complex in nature, where ability to recognize deviation from accepted practice is requiredNormally receives minimal instructions on routine work, and minimal instructions on new assignments



Position Requirements:Education Required: High School Diploma / GEDEducation Preferred: AA Degree or some collegeExperience Required: 3 years related experienceExperience Preferred: 4-6 years related experienceSpecialized or Technical Knowledge Licenses, Certifications needed: N/ACompetencies: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it



TechnicalStrong computer literate and experience using "Windows" computer software applications such as Word and Excel. Excellent oral and written communication. Ability to proofreadExperience with Business Applications such as Oracle, Electronic Document Management System, and LIMs is strongly preferred.Experience with Scientific and/or Pharmaceutical terms is required.



Planning & OrganizationalStrong organization and time management is required.Able to work with the production schedule and plan accordingly as documentation is issued 10 business days in advance of scheduled run.Able to adapt to changes in schedule and respond accordingly in order to issue current, effective documentation.Ability to work in environment with interruptions/urgent requests and resume previous activities seamlessly.Overtime/Off Shift On-site support may be required.InterpersonalExcellent interpersonal skills are required as this position requires daily contact with our internal customers. Teamwork is essential as coordination between Documentation Control personnel is mandatory.CommunicationProficient verbal communication skills are required as this position requires contact with our internal customers.Autonomy and Independence

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Job Details

  • ID
    JC17129598
  • State
  • City
  • Job type
    Contract
  • Salary
    $30 - $35 /hr
  • Hiring Company
    Stefanini
  • Date
    2021-07-21
  • Deadline
    2021-09-19
  • Category

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