Quality Assurance Associate - Clinical Trials

Summary - Under the direction of the Quality Assurance Manager, responsible for performing internal & vendor audits & assisting w/ Quality Assurance tasks.

Responsibilities

• Assist w/ monitoring implementation of the quality management system (QMS) & report observations/recommendations/findings via internal audits
• Track overdue training & send notifications, as necessary
• Assist w/ preparation & facilitation of QM meetings
• Assist w/ the noncompliance reporting process, follow-up, & metrics/trending
• Assist w/ tracking corrective actions/preventative actions (CAPAs) from establishment to completion & performing & reporting any required verifications of effectiveness (VoEs)
• Assist w/ writing & reviewing QAU SOPs
• Make recommendations for organizational continuous quality improvement (CQI)
• Audit/inspect study conduct, documentation, sites, facility records, & vendors to ensure compliance w/ regulatory/certification/accreditation requirements, protocols, & SOPs
• Schedule, perform, & report vendor audits & assist w/ scheduling, performing, & reporting on-site/remote vendor inspections per the vendor audit/inspection plan
• Report findings directly to the project manager (for study-specific audits/inspections, the Laboratory Director, the Chief Operating Officer, or their designee
• Review new & revised (non-QAU) SOPs, attachments, & other documents for compliance w/ supervision
• Assist w/ preparing for, hosting, & responding to external audits/inspections
• Communicate effectively w/ internal personnel to identify & promptly resolve quality issues
• Comply w/ the Employee Handbook (official Cenetron employees only), Cenetron SOPs, policies, & agreements
• Potential biohazardous environment – Entry into the laboratory (where the handling of chemicals, blood & blood products, & temperature-sensitive products occurs) may be required

Expertise and Fund of Knowledge

• Working understanding of the technology used in laboratory tests
• Ability to proactively direct and promote teamwork in a multi-disciplinary team setting
• Basic understanding of the role & responsibilities of central laboratories in the clinical trials market
• Ability to interpret relevant GCP, GCLP, CLIA, CAP, NYSDOH, & FDA regulations, requirements, & guidelines regarding the conduct of clinical trials & laboratory management
• Basic understanding of the terminology, design, goals, & other key features of research & clinical trial protocols
• Basic understanding of the technology used in laboratory tests & research & development
• Strong ability to read/fully dissect technical documents & extract pertinent (or identify incorrect) information
• Strong ability to write SOPs & technical documents w/ minimal supervision

Computer Skills

• Microsoft Office applications including Word, Excel, and PowerPoint.
• LIMS application experience desirable

Qualifications

• Accredited BA/BS degree in a science or quality field or equivalent combination of education, training, & experience
• A minimum of 2 years’ experience &/or training supporting regulated research, preferably in a quality assurance or quality control capacity or equivalent combination of training, education, & experience in regulated research preferred
• Previous experience w/ quality review of regulatory documents & auditing preferred
• Successfully works independently & in a team environment
• Strong organizational & verbal/written communication skills including excellent grammatical & proofreading skills
• Ability to work in an organized & neat manner
• Ability to prioritize & handle multiple tasks effectively
• Self-motivated & detail-oriented
• Successfully applies problem-solving skills
• Computer literacy & ability to quickly acquire new computer-related skills

Job Type: Full-time

Pay: From $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 2 years (Preferred)

Work Location: In person