Quality Assurance Generalist

Proclinical is currently recruiting for a Quality Generalist Contractor with a leading biotechnology company located in Philadelphia, PA. As the QA Generalist, you will participate in the activities related to product manufacture, Quality investigations, auditing, change control, CAPA, raw material, intermediate, in-process and final product release.

Job Responsibilities:

• Act as a champion for Quality understanding and compliance with the requirements of CGMP with some experience with GCP.
• Provide GxP training and support to departments.
• Review master batch records, validation documentation, specifications, reports and forms; Author and/or review SOPs as necessary.
• Maintain and organize GxP documentation, in both electronic and hard copy formats; Provide support on the use and administration of the EDMS and LMS.
• Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and regulatory requirements.
• Participate in the batch assessment process to facilitate the timely release of products.
• Initiate investigations, root cause analysis, risk assessments and implementation of change controls and CAPAs, as appropriate.
• Participate as cross-functional team member for process validation, analytical validation and technical transfer projects.
• Evaluate non-conformances; identify CAPAs.
• Review and coordinate change requests.

Skills and Requirements:

• Bachelor's Degree in a scientific discipline.
• Minimum of 5 years hands-on experience in biopharmaceutical operations, technical operations and/or quality operations.
• Minimum of 3 years' experience in Quality function that supports compliance activities within a GMP manufacturing facility / global pharmaceutical environment.
• Knowledge of GMP, GCP ICH and FDA biologics regulations.
• Cell and gene therapy experience preferred.
• Experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
• Demonstrated knowledge of document control systems, preferably electronic systems.

If you are having difficulty in applying or if you have any questions, please contact Christian Delbaere at (+1) 347-227-1672 or c.delbaere@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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