Quality Control Associate I

US-GA-Union City
Job ID
2017-1068
Category
Quality Control

Overview

Responsible for performing daily lab operations with the assigned functional area related to the release of product, and/or monitoring of the IMF environment, as well as complete other assigned duties.

Responsibilities

  • Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing.
  • Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods may include flow cytometry, ELISA, endotoxin, complete blood count, viability, gram stain, growth promotion, and sterility.
  • Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures.
  • Initiates and takes ownership as needed of laboratory investigations and exception reports for out-of-limit samples, and of other projects and related assignments.
  • Performs routine laboratory equipment maintenance.
  • Revises and updates standard operating procedures.
  • Performs testing in support of method validation studies.
  • Adheres to good documentation practices to ensure data integrity and traceability

Qualifications

  • Associate or Bachelor’s (preferred) degree in a scientific discipline or equivalent.
  • Typically 2+ years related experience in cGMP/FDA regulated industry.
  • Knowledge of basic lab testing techniques.
  • Basic level of analysis skills required to evaluate and interpret data to arrive at logical conclusions.
  • Attention to detail, quality and compliance with strict adherence to test procedures and protocols.
  • Ability to learn new technologies and processes quickly and to understand the technical concepts behind each assay performed.
  • Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
  • Proficient in MS Office applications.

 

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