Manufacturing Document Specialist

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.

Duties/Responsibilities:

  • 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

Compensation: DOE

Assignment Type: Contract to hire

Location: Houston, TX

For immediate consideration, please send your resume to [email protected]

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