Quality Control Associate II

US-CA-Seal Beach
Job ID
2017-1045
Category
Other

Overview

Dendreon is looking for a Quality Control Associate II with 5+ year’s related experience in cGMP/FDA regulated industry. This person will be responsible for performing daily lab operations within the assigned functional area related to the release of product, and/or monitoring of environment, in addition to other tasks related to the overall productivity and operation of the department. Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.

The QC Associate II normally receives no instructions on routine work, general instructions on new assignments, and works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.

This job is performed in a lab, office, or utility (noisy) environment, and this person may be required to work alternate shifts.

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.
  • Performs routine laboratory equipment maintenance.
  • Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • 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 for invalid assays and non-conformance and exception reports for out-of-specification test results, as well as perform impact assessment and root cause investigation.
  • 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. 
  • Performs stability tests including cell culture and immunoassay methods.
  • Participate in and initiate other projects and related assignments.
  • Assists with training of QC personnel.
  • Able to organize and provide analytical data with some supervision upon request.

Qualifications

  • Associate's or Bachelor’s (preferred) degree in a scientific discipline or equivalent. 
  • 5+ years related experience in cGMP/FDA regulated industry. 
  • Strong knowledge of basic lab testing techniques.
  • Intermediate level of analysis skills required to evaluate and interpret data to arrive at logical conclusions.
  • Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys).
  • 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.
  • Proficient in MS Office applications.
  • Ability to sit or stand for extended periods of time.
  • Intermittent walking to gain access to work areas.
  • Finger dexterity sufficient to use a computer and to complete paperwork activities.
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
  • Hearing sufficient to communicate with individuals by telephone and in person.
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas. 
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • Ability to gown aseptically for work in Clean Room environments.
  • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

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