Job Title: Manufacturing Document Specialist
Job Description: Element Staffing is recruiting for a Manufacturing Document Specialist for a pharmaceutical company in Houston, TX. This individual will be responsible for activities involving compliance with applicable regulatory requirements and internal policies within the manufacturing group. Experience with technical writing is a must, as the position requires the production of high-quality technical documentation including deviation and investigations reports, SOPs, and other supporting documentation. Previous experience in a GMP or bioprocessing environment is a plus.
- 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.
Years of Experience: 1-3+ years
Education: AS/BS or equivalent experience
Shift/Travel: M-F, 8a-5p + OT as needed
Assignment Type: Contract to hire
Location: Houston, TX
For immediate consideration, please send your resume to [email protected]