Create, revise, and format new or existing documents (MBRs, SOPs, forms, jobs aids, technical documents, worksheets, etc.) and assists in tracking each revision
Facilitate the review/approval of all technical documents through the electronic document management system
Collaborate within department and cross-functionally to meet set objectives and execute against manufacturing schedule.
Participate in regular site and Quality/Manufacturing meetings.
Participate in audits and regulatory inspections as assigned.
Other duties as assigned.
Requirements:
Bachelor’s degree in biological science, chemistry, or related discipline with at least 2-4 years of document review and technical writing work experience
Minimum of 2-4 years of experience in the pharmaceutical / biopharmaceutical industry.
Good knowledge of biologics cGMP manufacturing ideally including recombinant protein and cell therapy cGMP manufacturing.
Knowledge / Skills / Abilities:
Experience producing and organizing content with a logical flow.
Experience with electronic document management systems.
Experience writing, proofreading, and revising GMP documentation.
Strong verbal, written, and interpersonal communication skills.
Proficiency in computer use and Microsoft Office applications.
Proven ability to work independently and analyze and resolve issues that impact quality.
Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
