Manufacturing Document Specialist

The Manufacturing Document Specialist will be responsible for activities involving compliance with applicable regulatory requirements and internal policies within the Manufacturing Group.

ESSENTIAL DUTIES and RESPONSIBILITIES include the following. Other duties may be assigned.

· Performs the compliance review and approval of all manufacturing batch documentation related to disposition of products

· Author/Review deviations and investigations

· Writing/Reviewing Standard Operating Procedures for manufacturing department

· Review Master Production Records

· Performing routine internal audits of Manufacturing processes

· Write and review protocols for development reports, IQ/OQ's and validations

· Follows Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs)

· Other duties as assigned or determined by Area Management

EDUCATION and/or EXPERIENCE

· Associate's Degree or equivalent; or one to three years related experience and/or training; or equivalent combination of education and experience.

· Experience with plasmid purification and microbiology techniques is preferred.

· Technical writing experience is a must. The technical writing aspect will utilize knowledge, experience and understanding of documentation best practices to produce high-quality technical documentation including deviation and investigation reports, SOP's, and other supporting documentation.

· Bioprocessing and GMP experience is a plus.