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