Quality Assurance Specialist III

Build your future at Curia, where our work has the power to save lives. The Quality Assurance (QA) Specialist III maintains Quality databases and provides an on-the-floor QA presence and oversight to operations, identifying compliance risks prior to and during execution to avoid deviations and manage immediate corrective action.

Responsibilities

• Represent Curia Quality Assurance when managing issues that require immediate corrective action, ensuring such action is appropriate and correctly documented.
• Review quality control testing for compliance with internal SOPs and specifications.
• Report personnel performance to appropriate management, highlighting areas and individuals in need of improvement as well as those exceeding expectations.
• Author, review, and/or approve Quality Management System documents, including change controls, SOPs, deviations, CAPAs, etc.
• Perform and/or participate in internal audits, external audits, investigations, and/or inspections.
• With supervision, respond or manage responses to clients regarding manufacturing, testing, and/or documentation issues.
• Develop and/or maintain Quality System metrics for management review.
• Provide on-the-floor support to operations, coordinating and performing day-to-day activities as needed.
• Assist in developing and conducting training of personnel to execute production in full accordance with cGMP’s and Curia’s quality system to ensure real-time compliance.
• Perform QA visual inspection activities when required.
• Participate in regulatory and client audits.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Chemistry or a relevant field and 5 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry, OR
• Master’s degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry.

Skills

• Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211 (preferred).

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.
• And more!

Pay

Pay Range: $92,000-$114,800/yr. Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.