Vacancy expired!
Do you have attention to detail? Are you interested in exploring career in Regulatory affairs for bio-pharmaceutical and diagnostic industries ? We are looking for a Quality Assurance (QA) Assistant.
Machaon Diagnostics is a diagnostic reference laboratory and a clinical research organization (CRO) specializing in the diagnosis, monitoring, and treatment of hemostatic and thrombotic conditions, diseases of the complement system, and associated rare genetic disorders. We are looking for a passionate, motivated, intellectually eager, recent college graduate interested in learning and developing regulatory affairs experience in the areas of: clinical diagnostic reference laboratory, clinical contract research, and clinical trials, for our growing Quality Assurance (QA) Department.
Responsibilities:
Main responsibilities of QA Associate include, but are not limited to
a. Ongoing document control duties for quality assurance policies and procedures
b. Learn, understand, and execute various tasks related to current and proposed applicable state, federal and international regulations, including CLIA, GLP, GCP, GCLP, GMP, CAP, HIPAA and GDPR
c. Assist with various clinical diagnostic quality assurance tasks and associated documentation
d. Assist with various tasks related to clinical trials including, but not limited to: Institutional Review Board (IRB) documentation, subject recruitment, subject screening/scheduling/management, and performance of research related testing
e. Adhere to Machaon policies and procedures as directed by the Supervisor, Manager, and or Director of associated departments
Minimum Position Requirements:
a. B.A./B.S with coursework in chemistry, biochemistry, immunology, molecular biology, statistics and related subjects required.
b. Clinical Laboratory Scientist (CLS) experience, a plus
c. 6 months or more related experience preferred.
d. Strong organizational skills
e. Strong communication skills
f. Proficiency in MS Excel, Word, Power Point
g. Must reside locally
Please send resume and cover letter via e-mail to: Delanda@MachaonDiagnostics.com
Machaon Diagnostics is California’s only independent bleeding and clotting laboratory, located in Oakland on the Summit Campus of Alta Bates Summit Medical Center. Machaon Diagnostics is a CA-licensed, CLIA-accredited, CAP-accredited clinical laboratory approved to provide high-complexity clinical lab testing services.
