SUMMARY

Under supervision of Manager, Quality Assurance, the Quality Assurance Associate - Pre-Clinical / GLP ensures the quality and regulatory compliance of Pre-Clinical and Good Laboratory Practice (GLP) studies. The Quality Assurance Associate is responsible for working with Manager, Quality Assurance and personnel at SCI to facilitate adherence to quality principles and compliance with Standard Operating Procedures, study protocols, and applicable regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Under the guidance of Manager, Quality Assurance, assists with maintenance of SCI’s Pre-Clinical and Good Laboratory Practice (GLP) quality program.
• Identifies and collaborates with Manager, Quality Assurance to recommend solutions to Pre-Clinical and GLP quality issues; promotes and facilitates continuous improvement.
• Ensures compliance with GLP (21CFR Part 58) and relevant regulatory requirements.
• Authors, reviews and maintains Quality Assurance Standard Operating Procedures (SOPs).
• Coordinates review and development of SCI SOPs and manages SOP updates and distribution.
• Reviews study protocols and SOPs for compliance with GLP regulations (21CFR Part 58).
• Schedules and conducts critical phase inspections for GLP studies.
• Monitors GLP study activities to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in compliance with the GLP regulations.
• Prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan and suggests recommendations for improvement. Conducts follow up activities as needed to monitor corrective actions.
• Prepares and issues GLP Quality Assurance Statements for inclusion in final reports.
• Coordinates and maintains properly indexed quality assurance records, including study-specific files, inspection/audit status reports, protocols and amendments, internal facility inspection reports, and other quality records.
• Under the direction of the Manager, Quality Assurance, assists with client/sponsor audits and regulatory inspections; leads tours, provides requested documents, and answers auditor/ inspector questions.
• Participates in or conducts project specific, system, facility, subcontractor, and vendor audits.
• Acts as GLP consultant to SCI staff.
• Conducts training on regulatory requirements and quality initiatives.
• Reviews equipment qualification protocols, data, and reports.
• Conducts quality reviews of computer system validation reports in accordance with 21 CFR Part 11 and Foundation process and procedures.
• May participate in equipment and software validation efforts.
• Other job duties as assigned.

QUALIFICATIONS

• Bachelor’s Degree in a scientific or health-related field required.
• Prior experience/training in preclinical biomedical research environment required; medical device and/or GLP (21 CFR Part 58) experience preferred.
• Strong attention to detail and willingness to learn are critical and developing knowledge/ understanding of FDA GLP regulations (21 CFR Part 58) and quality principles is expected.
• Must be computer literate and proficient in Microsoft Word, Excel, PowerPoint and Outlook.
• Experience with computer system validation and 21 CFR Part 11 is strongly preferred.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow up and judgement. Must be able to prioritize.
• Ability to analyze information and solve problems relating to quality assurance.
• Willingness to learn applicable regulations and industry-related knowledge.

BENEFITS

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through TransitChek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year

COMPENSATION

The hiring range for this position is $65,000 - $70,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CONTACT INFORMATION

To be considered for this opportunity, please submit your resume.

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CRF is an equal opportunity employer.