QA And Method Validation Specialist

Looking for a great QA Specialist with Method/Equipment Validation Experience to join our Pharmaceutical Team!!

HYBRID: with onsite being Tues/Wed/Thur and REMOTE: Mon and Fri

Additional Skills & Qualifications:

• Biologics, large molecule analytical experience
• Experience in Method and Equipment Validation
• QA Experience with Change Controls, Deviations and QA Manufacturing
• BS or BA in analytical chemistry, biochemistry, pharmaceutical development or equivalent degree.
• 5 years of relevant experience in a GMP environment related field
• Varying levels of knowledge in laboratory controls and method validation per FDA/EU/ICH/USP guidelines.
• Prior experience in pharmaceutical industry

Description:

• Reviews and approves method validation and transfer related documentation and exception events.
• Partners with Commercial and Development Quality Assurance Biologics colleagues to ensure testing requirements are met in a timely and compliant manner in alignment with manufacturing and release expectations.
• Manages daily QA team activities, leading major planned changes and exceptions, method validation and transfer related documents, deviations, investigations.
• Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders.
• Serves as QA project support, leads complex quality issues and events, represents escalations as the Analytical QA expert, and authors concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).

Skills:

analytical chemistry, Quality assurance, pharmaceutical industry

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.