Quality Assurance Specialist II
Curia · Rensselaer, NY · 3 wk ago
Quality Assurance$67k–$83k/yrFull-time
About the role
The Quality Assurance (QA) Specialist II at Curia is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks, avoiding deviations, and managing immediate corrective actions.
Responsibilities
- Represent Curia Quality Assurance when managing issues requiring immediate corrective action.
- Ensure such action taken is appropriate and correctly documented.
- Review quality control testing for compliance with internal SOPs and specifications.
- Report back to appropriate management about personnel performance, highlighting areas needing improvement and 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.
- 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, including coordinating and performing day-to-day activities as needed.
- Absorb and 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.
Requirements
- BA/BS 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 OR MA/MS Degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry.
Qualifications
- Excellent written and verbal presentation and communication skills.
- Strong facilitation skills.
- Strong problem-solving skills, with the ability to resolve conflict.
- Comfortable working independently and proactively in combination with individuals in other departments across the organization.
- Focused self-starter with attention to detail and ability to multi-task.
- Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211.
- Working knowledge of Microsoft Office or other software as needed.
Physical requirements
- Sit.
- Use hands to finger, handle, or feel.
- Talk or hear.
- Reach with hands and arms.
- Stand.
- Climb or balance.
- Stoop, kneel, crouch, or crawl.
- Lift and/or move up to 50 pounds.
- Close vision.
- Adjust focus.
Work environment
- Potential exposure to fumes or airborne particles and toxic or caustic chemicals.
- Exposure to wet and/or humid conditions.
- Motion of mechanical parts.
- High, precarious places.
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