Quality Assurance Specialist

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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