Gclp Quality Assurance Specialist

Title- GCLP Quality Assurance Specialist

Duration – 12+months (extension)
Location – Bethesda, MD

Responsibilities:

Responsibilities:

• Develop and implement quality control reporting systems.
• Serve as the subject matter expert for GCLP and GLP compliance-related inquiries from both internal and external stakeholders.
• Perform internal inspections to ensure compliance with GCLP standards on a regular (e.g. during testing, monthly, or quarterly basis as required).
• Provide assistance in the SOP management.
• Maintain all master document inventories, program schedules, training files, word documents, and drafts with the Federal Task Leader and relevant GCLP staff.
• Perform or delegate laboratory equipment control documentation and schedule necessary/routine preventative maintenance.
• Review study documentation with management to ensure completeness and ensure proper archival of trial-related materials.
• Maintain archives with proper disposal of documents according to record retention guidelines.
• Prepare appropriate documentation and respond to requests for GCLP inspections and internal/external audits.
• Provide support to management in preparing, tracking, and responding to deviations and CAPA.
• Provide guidance and recommendations for development and improvement of the Quality Assurance and archival programs.
• Adjust quickly to changes in schedule as priorities shift.
• Wear appropriate Personal Protective Equipment (PPE) when in BSL-2 laboratories.
• Work collaboratively with team members to ensure necessary information is cataloged, digitized, and archived at the end of a study.
• Sustain close and effective communications with VIP management and external collaborators.

Experience Required / Requirements:

• BS with 5+ years of experience in a GCLP environment, working with Quality Assurance.
• IT skills such that candidate knows or can quickly learn to utilize LIMS, CQMS, ELN, Microsoft Office, etc.
• Ability to work well with others and independently.

Job Type: Contract

Salary: $45.00 - $50.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Office

Ability to Relocate:

• Bethesda, MD 20892: Relocate before starting work (Required)

Work Location: In person