Minnnesota Bioscience Jobs

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OraSure Technologies, Inc. Quality Assurance Specialist in New Brighton, Minnesota

  • Maintains knowledge in FDA and OECD GLP regulations, GCP regulations as well as domestic and international guidance documents and CAP/CLIA requirements

  • Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards.

  • Ensures SOPs, forms and other controlled documents are current and reflect laboratory processes and meet regulatory requirements.

  • Assists in reviewing, writing and maintaining up-to-date SOPs and controlled documents for unit.

  • Updates the master schedule as required by GLPs.

  • Other duties as assigned by management.

  • Bachelor’s degree in biology, chemistry or related field.

  • At least 2 years of experience in Quality Assurance or Quality Systems.

  • Experience in GLP regulations

  • Familiarity GCLP, regulated guidance and CAP/CLIA requirements.

  • Any equivalent combination of education and experience

  • Knowledge of regulations and guidance applicable to working as laboratory QA

  • Detail-oriented and highly organized

  • Effective oral and written communication skills

  • Excellent interpersonal skills

  • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, Powerpoint, Box and Dropbox

  • Ability to multitask and work under pressure of multiple projects and deadlines

  • Ability to effectively prioritize workload and manage changes in direction

  • Must be able to record and keep essential records for a regulated environment.

Diversigen is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.

Job ID: 2020-1231

Street: 600 County Road D, West, Suite 8

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