Pharmaceutical Quality Specialist – Documentation Specialist Position Available In Wake, North Carolina
Tallo's Job Summary: The Pharmaceutical Quality Specialist - Documentation Specialist role involves overseeing GMP documentation for site startup activities. Responsibilities include reviewing and approving documents, ensuring compliance with regulatory requirements, and collaborating with SMEs. The pay range for this position is $30 - $37 an hour.
Job Description
Job Description:
Responsibilities:
Qualifications, skills, and all relevant experience needed for thisrole can be found in the full description below. The candidate will be primarily responsible for providing qualityoversight of GMP documentation associated with site startupactivities. Key responsibilities include reviewing and approvingGMP documents, coordinating with site subject matter experts (SMEs)to ensure document adequacy, and communicating progress on actionsand deliverables to senior management.
Key Responsibilities:
Ensure timely and accurate review and approval of GMP documentswithin the applicable GMP systems. Evaluate documents for compliance with regulatory and proceduralrequirements, and coordinate with functional SMEs to obtainadditional information when necessary. Complete document approvals within established timelines andcommunicate status updates and responses to the Senior Managerlevel. Collaborate with other departments within to supportcross-functional initiatives related to GMP documentation. Prioritize documentation workflows, maintain a strong understandingof review processes, and ensure adherence to quality standards andtimelines. Perform other duties as assigned by the supervisor.
Pay Range:
$30 – $37 an hr.
