Senior Specialist, Quality Assurance

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Prepare and execute QA audits.

• Create audit reports and relay findings to QA management and pertinent external stakeholders.

• Collaborate with teams to ensure corrective and preventative actions address QA observations.

• Analyze and utilize critical-to-quality factors to pinpoint potential risks.

• Prepare for and conduct risk-based audits.

• Influence, partner, and collaborate with colleagues both within and outside the team.

• Perform GCP audits of investigator sites, suppliers, third-party collaborations, and due diligence activities.

• Assist QAL in identifying audit substrates for scheduling in accordance with risk assessments.

• Report quality issues, potential misconduct, and significant project/product deviations to the QAL and TA Head.

• Provide daily QA functional-line support for quality oversight of assigned studies.

• Aid in Clinical Quality capacity planning and the assignment of GCP audits.

⛳️ Requirements

• A minimum of 3 years of relevant industry experience for candidates with a BS/BA degree or equivalent and/or experience in a related field.

• Strong proficiency in the primary activities and essential skills necessary for the role.

• Familiarity with compliance audits.

• Knowledge of Clinical Quality Management.

• Understanding of clinical trials.

• Knowledge of data integrity.

• Awareness of Quality Assurance (QA) and QA standards.

• Familiarity with Quality Assurance systems.

• Detail-oriented mindset.

• Strong interpersonal relationship skills.

• A valid driving license.

• Willingness to travel 50%-70% (the posting also states travel requirements of 75%).

• No visa sponsorship available.

🏝️ Benefits

• Eligibility for an annual bonus.

• Long-term incentive eligibility, if applicable.

• Medical, dental, and vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave days.

• Sick leave.

• Remote work arrangement.