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Temp – Documentation Coordinator in Rensselaer, NY at AMRI

Date Posted: 1/8/2019

Job Snapshot

Job Description

Temp Documentation Coordinator, Rensselaer NY 


The Temp Documentation Coordinator is responsible for assuring accuracy and completeness of manufacturing monographs, releasing, batch record review as well as assessing and communicating to the supervisors those situations requiring attention and/or correction.


MAJOR DUTIES AND RESPONSIBILITIES

 
  1. 1.      Formats and prepares master manufacturing and cleaning batch records in support of manufacturing activities. 

    2.      Maintains manufacturing batch record master file, historical file, and master lists.

    3.      Review, file and organize release documentation for raw, in-process and bulk materials.

    4.      Reviews supplier qualification status and documents in support of raw material release.

    5.      Release raw materials and intermediates for use in manufacturing.

    6.      Assists in review of repackaging batch records for compliance prior to material being shipped by warehouse.

    7.      Assists in review of batch records for accuracy, completeness, resolves, etc.


Job Requirements

Education and/or Experience

  • •         Minimum Two-year degree in science.

    •         Comprehensive knowledge of cGMP’s and SOP’s and documentation requirements of validation.

    •         Working knowledge of production and R&D operations and equipment.

    •         Thorough knowledge of word processor and computer, including good typing skills for both.  Working knowledge of Oracle ERP or similar systems desired, but not required.

    •         Must have excellent interpersonal, organization, oral, written, and typing skills.

    •         Ability to evaluate daily situations and determine action/source needed for corrective action when required.


All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.


Shift:  First Shift

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.