Analyst III/Manager, Raw Materials

Job Locations US-MA-Bedford
Posted Date 2 months ago(8/8/2022 2:28 PM)
Job ID
2022-1535
# of Openings
1
Category
Quality

Overview

Manage raw materials testing, both in house and external. Execute routine and non-routine quality control testing activities as assigned by management. Take the lead on CAPA’s, change controls, investigations, and deviations related to raw materials. Manage transfer of methods to QC from external testing laboratories. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.  

Responsibilities

  • Responsible for the support / management of raw material program. This includes:
    • Overseeing material qualification and reports
    • Coordinating / performing testing of raw materials
    • Aliquoting and shipment of materials to contract laboratories
  • Determination and creation of testing requirements and specifications based on USP 
  • Transfer of external methods in house
  • Participate in QC Analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, etc).
  • Manage QC inspection / AQL activities related to products.
  • Author technical reports as required.
  • Coordinate with supervisor on scheduling of testing for reagents and product samples.
  • Participate in data review.
  • Coordinate external outsourcing of testing.
  • Participate in method improvements and optimization activities to improve throughput
  • Lead CAPA, change controls, investigations, and deviations and the timely closure of these items.
  • Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)
  • Adherence to cGMPs at all times.
  • Supervise Analyst I, Raw Materials as necessary

Qualifications

  • Bachelor’s degree in Chemistry or related field
  • 5+ years’ work experience
  • HPLC / UPLC experience required
  • Knowledge of USP required
  • Knowledge of CFR 210,211, EP, and FDA/ICH guidance preferred
  • Operation in a GMP, GDP, GLP industry experience preferred
  • Knowledge of safe laboratory practices
  • Strong verbal and written communication skills

Working Conditions:

  • Mix of office and laboratory environments.
  • Must be able to work in chemical laboratory environments.

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