Jobs · Quality Assurance · Massachusetts

Quality Control Analyst I

LGC · Milford, MA · 2 wk ago
On-siteQuality Assurance$26/hrFull-time

About the role

The Quality Control Analyst I position focuses on the characterization of biological materials and provides support to manufacturing with timely and accurate in-process and final product testing. Key areas of responsibility include routine testing, data analysis, clean room environmental monitoring, equipment calibration, preventative maintenance, and documentation.

Responsibilities

  • Accurately perform routine testing with ELISA, immunoassays, bioburden, Western Blot, endotoxin, and sterility testing, and other test methods on infectious and non-infectious raw material samples and finished biological products.
  • Analyze and record testing data with a focus on accuracy, ensuring timely work impacts other groups to meet critical customer deadlines.
  • Perform routine clean room environmental monitoring and water system sampling.
  • Ensure testing equipment is calibrated prior to use.
  • Perform weekly and monthly preventative maintenance to ensure equipment is working properly.
  • Maintain an accurate electronic database of sample submission, testing, and final disposition.
  • Produce and use control charts. Perform tracking and trend analysis on laboratory data.
  • Performs quality control duties including, but not limited to; daily temperature log entries, emptying biohazard trash, etc.
  • Document technical problems, report problems to Supervisor.
  • Adhere to company Standard Operating Procedures, as well as, regulatory agencies and customer requirements.
  • Comply with cGMP and ISO standards at all times to support LGC’s commitment to Quality.
  • Aid in the implementation of corrective actions in response to internal and external audits.
  • Maintain the appearance of the QC lab on a daily basis for audit readiness.
  • Follow Operational Excellence principles, e.g., removal and disposal of expired chemicals and reagents, removal of broken equipment and unused equipment and supplies from the laboratory.
  • Perform other duties as required, or assigned by management, to meet business needs.

Qualifications

  • Minimum Qualifications: Bachelor’s degree in science or related field with 1-2 years related experience
  • An understanding of immunoassays is required.
  • Ability to work on problems of simple scope where analysis of situations or data requires a review of a variety of factors.
  • Excellent verbal and written communication skills in English are essential, including the ability to communicate technical problems in a clear, concise manner.
  • Action oriented, able to take initiative to perform routine tasks without being asked.
  • Experience with Microsoft Software (Word, Excel, Office).
  • Basic mathematical skills are required.
  • Good organizational skills
  • Sharp attention to detail
  • Must be a positive team player with excellent interpersonal skills.

Preferred Qualifications

  • Skilled in performing ELISA’s is desirable.
  • Previous experience with automated chemistry analyzers and immunoanalyzers is desirable.
  • Previous experience in a regulated laboratory setting is desirable.

Competencies & Behaviors

  • Resonate and operate in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
  • Continuous learner, always seeking opportunities to learn how to perform new assays.
  • Adaptable, with the capacity/flexibility to respond to the demands of a growing/changing company.
  • Complete the existing workload under supervision.
  • Communicate & collaborate across teams for day-to-day activities.
  • Possess a strong work ethic
  • Performance driven

Additional Information

The customary salary range for this position is:

  • Minimum pay rate: $26.00 USD per hour
  • Maximum pay rate: $39.00 USD per hour

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