Description:

• Verify GMP compliance to applicable Standard Operating Procedures and regulations by performing audits. • Promote Quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System. • Host client audits, perform external audits at clinical and/or vendor sites. • Participate in the development Corrective and Preventive Action (CAPA) plans, and contribute to resolution of audit findings, under direct supervision of the Project Lead. • Assist with quality assurance (QA) audits (including document and process audits) per procedure. • Develop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc., under the direct supervision of the Project Lead. • Assist with project management activities associated with quality projects, including maintenance of project information. • Observe and adhere to applicable regulatory and legal requirements. • Perform Quality Control (QC) of scientific documents and reports, as requested. • Interact directly and with clients and demonstrate strong client interaction skills. • Participate in company and departmental process improvement and recommend suggestions to improve efficiencies. • Represent self and company in a professional manner and in line with core company values. • Practice excellent internal and external customer service, communication, and teamwork. • Support objectives and improvement efforts within department and organizationally. • Comply with all applicable policies, procedures, and training requirements.

Skills:

Biologics, Quality Assurance, audit, gmp, fda, quality management system, 21 CFR Part 11

Top Skills Details:

Biologics,Quality Assurance,audit,gmp

Additional Skills & Qualifications:

• 5 years of related experience or relevant pharmaceutical, health authority and/or CRO experience • Prior experience in a Quality Assurance department required • Provides oversight and development of Quality Management Systems (QMS) • Familiarity with ISO 9001:2015 • Familiarity with 21 CFR Part 11, FDA, and GMP requirements. GCP GXP is preferred

Experience Level:

Expert 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.