Quality Specialist Jobs

About The Position

Requirements

• Requires a minimum of two (2) years of experience performing quality control reviews of documents and/or records.
• Requires an Associate Degree from an accredited technical/vocational institute, college, or university.
• Knowledge of regulations and requirements governing the conduct and documentation of nonclinical/preclinical research protocols.
• Knowledge of medical and scientific terminology.
• Excellent written, verbal, communication, and interpersonal skills.
• Proficiency with Microsoft Office Suite, particularly Word and Excel.

Nice To Haves

• Bachelor’s Degree from an accredited four-year college or university.
• Knowledge of FDA regulations related to Good Laboratory Practice (GLP), including 21 CFR Part 58, the Animal Rule, and electronic records/electronic signatures under 21 CFR Part 11.

Responsibilities

• Performs quality review of data, summary tables, and reports for completeness, accuracy, and compliance
• Prepares clear, concise QC Review Reports, with corrective actions required, for the Study Director.
• Reviews and assesses study related processes and procedures.
• Assists with maintaining Maintains corrections tracking.
• May assist during inspections by external monitoring authorities and study sponsors, and with the identification and implementation of corrective and preventative actions in response to any observations.
• Meets regularly with the Study Directors/Study Compliance Manager to report the status of studies assigned and any findings, corrective actions and any potential compliance issues.
• Identify deviations in experimental procedures, sample handling, or data reporting that may impact study integrity or regulatory compliance.
• Maintains organized documents pertaining to Animal Rule Studies.
• May participate in additional Quality Control activities as assigned.
• Types or e-mails QC correspondence or other documents using a PC.

Benefits

• Comprehensive health, dental, vision, and life insurance coverage for you and your family—including pet insurance options.
• Competitive employer-funded retirement plan with 6% contributions starting on day one, increasing with years of service.
• Generous paid time off, including 14 paid holidays and a paid Winter Recess (from the last week of December through New Year’s).
• Paid time off for short-term illness and mental wellness, helping you take the time you need when life happens.
• Volunteer Time Off (VTO) to encourage giving back to the community.
• Paid parental leave to support you and your growing family.
• Flexible work arrangements that support a strong work-life balance.
• On-site medical clinic, wellness incentives, and prescription support programs designed to make care more accessible and affordable.
• On-site fitness center and wellness programs to help you stay active and healthy.
• Relaxed dress code so you can feel comfortable and be yourself at work.
• Dynamic learning environment with professional development opportunities, mentorship, tuition reimbursement, and leadership programs to support your growth.