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Scientific. Clinical. Software Engineering

QC Associate

Marin Metro Area, CA

Job Type: Scientific Job Number: JN -032020-26480 Region: Marin Metro Area

Job Description

Role Summary

The QC Product Analyst IV reports to a Quality Control Product Supervisor and/or manager and is responsible for the following:


Providing leadership, vision and daily test guidance to the Bio-Chemistry or Separations team

Performing testing and reports results to ensure a high level of quality and compliance

Resolving problems requiring in depth technical knowledge

Mentoring and providing guidance to junior staff


The position requires developed technical expertise, a strong understanding of quality compliance and GxPs, and good leadership skills. They will be expected to work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, performing routine testing, reviewing routine testing results, maintaining the laboratory in an audit ready state, performing investigations, and communicating laboratory issues to management and junior staff.


The QC Product Associate II must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. The position requires some combination of working experience and knowledge within some of the following methodologies:


Liquid Chromatography, Ion Chromatography, SDS-PAGE, Capillary Electrophoresis, Cell based biotechnology assays, Gas Chromatography, Spectroscopy, Solid oral dosage testing, Basic chemistry skills.


The QC Product Analyst IV must develop skills in the operation and routine maintenance of various analytical instruments and computers. They must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills to work with their supervisor/manager in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation.


Education Required


B.S./B.A. in Science (major in biology-biochemistry-chemistry) with 4+ years of relevant laboratory experience

Or

A.S. with at least 7 years of relevant laboratory experience

Experience Required

  • 4+ years in a cGMP/GLP laboratory; quality control experience is preferred.
  • Ability to follow written instructions and to perform tasks with direct or minimal supervision.
  • Demonstrate strong leadership skills through past work history.
  • Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel, LabWare LIMS, CMMS, and TrackWise.
  • Strong written, documentation, verbal, and communication skills.
  • Works independently as well in a team environment.

Supervisor Responsibility

Analysts and Senior Analysts may report to this position

Competencies Required

Behavioural

Accountability

Achieving Excellence

Communication

Courage / Challenge

Develop Self & Others

Judgement

Reliability

Teamwork

Technical

Technical Knowledge & Expertise

GMP Acumen

Critical Thinking & Evaluation

Organisational Awareness

Performance Management

Self-Knowledge

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