Quality Assurance Specialist job in Gaithersburg, USA

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Job type: Permanent

Discipline: Biological Sciences, Immunology, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Gaithersburg, MD.

Job Responsibilities:

Review of Clinical Immunology and other analytical records and data generated during the testing of vaccines for compliance to current Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and Standard Operating Procedures (SOPs) and protocols.
Develop reports based on records and data review
Assist teams in developing and implementing CAPAs
Follow up on corrective actions.
Handles non-routine situations for review and approval by senior staff
Independently generates controlled documents (i.e., SOPs, Specifications, Methods, Protocols, Training Materials, etc.)
Conducts final review and approval of GLP/GCLP data and associated documentation
Supports more complex Deviations and CAPA review and approval
Reviews more complex and technical Assay Validation activities
Assists in developing user requirement specifications and conduct risk assessments
Other duties as assigned

Skills and Requirements:

BS with 3-5 years of GXP industry experience
Excellent understanding of quality assurance systems
Strong communication and organizational skills
Excellent understanding of, GLP, GCP and GCLP expectations
This position is located onsite in Gaithersburg, MD

If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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