Quality Assurance Specialist - Document Control in Burlington, MA at AMRI

Date Posted: 12/4/2019

Job Snapshot

Job Description

Quality Assurance Specialist I in Burlington, MA

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by providing support to the cGMP compliance function at AMRI. This person will be responsible for the processing, formatting, obtaining approvals, mastering, and distribution and archival of Standard operating Procedures, Forms, Batch Records, Protocols, Material Specifications. The Quality Assurance Specialist I will need to send GMP documents to the clients for their review and approval.

In this role, you will:

 

  • Author and revises the Standard Operating Procedures
  • Assist in developing and delivering cGMP training
  • Provide support to manufacturing and QA operations
  • Participate in document identification, development revision, review, approval and distribution of new or revised documents
  • Assign DCN numbers, track and process through closure
  • Have responsibility for logbook and lab notebook issuing, tracking and reconciliation
  • Generate, issue and verify QC labels
  • Review executed documents prior to sending to clients and archival

Job Requirements

Qualifications and background to be successful in this role:

 

•         Associates’ degree in related field required; Bachelors’ degree preferred

•         3 years’ experience in GMP environment; Aseptic technique/manufacturing experience strongly preferred

•         Strong familiarity with the regulatory requirements of 21CFR210 and 211

  • Focused self-starter with attention to detail; team-oriented but able to work independently and proactively, and ability to multi-task
  • Strong problem solving and organizational skills
  • Experience working in a clean room with a thorough understanding of clean room personnel and material flows a must

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.