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QC Analytical Associate I

5 months ago

Lee, United States BERKSHIRE STERILE MANUFACTURING LLC Full time
Job DescriptionJob Description

Position Summary

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. Testing includes incoming materials, in-process samples, finished good and stability samples. It also includes performing experiments for method transfers, qualifications and validation. The QCA Analyst is responsible for creating and revising documents related to testing such as SOPs, test methods, protocols and reports. The position involves hands on activities such as laboratory testing, sampling of incoming materials, shipment of samples, inspection of samples and visual inspection of finished goods.

Duties and Responsibilities

  • Perform laboratory testing of incoming materials, in-process, finished product and stability samples
  • Create documentation necessary to conduct method transfers, qualifications, and validation and perform corresponding experiments
  • Author and revised quality control procedures and specifications
  • Perform laboratory maintenance activities such as temperature checks, ordering laboratory supplies, cleaning, appropriate disposal of laboratory waste
  • Maintain SDS collection
  • Sample and dispense chemicals and manufacturing materials
  • Prepare shipments of samples to contract testing laboratories, including interfacing with outside laboratories
  • Visual inspection of finished goods
  • Ability to work unscheduled and overtime hours as needed
  • Other duties as assigned

Regulatory Responsibilities

  • Compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

Supervisory Responsibilities

  • N/A

Experience

Zero to two (0-2) years of directly related experience. Up to one (1) year of experience in a cGMP environment under minimal supervision.

Education

  • Bachelor’s Degree

Knowledge, Skills & Abilities

  • Skilled in the use of Microsoft office applications such as Word, Excel, PowerPoint and Adobe Acrobat

Physical Requirements

  • Ability to stand and sit for prolonged periods of time
  • Able to lift up to 30lbs