Compliance Specialist Manufacturing - Biopharma
Posted on May 18, 2019 by Anonymous
A wide range of career advancements are available within Manufacturing and also support for understanding the process for those coming from outside Biopharma.
The site is roughly 900 strong at the moment and has plans to double in number in the following years, so career growth inside the company is almost a must.
Summary: Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures.
• As part of investigations review completed batch records and logbooks to ensure compliance with written procedure.
• Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
• Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes.
• Participates in cross-functional study teams to support and/or author investigations.
• Gathers, trends, and analyzes process related data to drive consistency and timeliness.
• Documents all training.
• Assists with training of new employees.
• Ensures all tasks are performed in a manner consistent with safety standards.
Experience And Required Skills :
Education and Experience:
• BS/BA in Life Sciences or a related field and 0-2 years of relevant work experience.
Relevant experience may be substituted in lieu of educational requirement