Biopharma Manufacturing Document Specialist ??? North Houston

Kelly Scientific Resources
Published
October 7, 2020
Location
Spring, TX
Category
Job Type

Description

Biopharma Manufacturing Document Specialist – North Houston

Kelly Scientific Resources is currently seeking a Manufacturing Document Specialist for a biopharma company in North Houston. As a Manufacturing Document Specialist you will be responsible for activities involving compliance with applicable regulatory requirements and internal policies within the Manufacturing Group.

Additional Job Responsibilities:

  • Perform the compliance review and approval of all manufacturing batch documentation related to disposition of products
  • Author/Review deviations and investigations
  • Review Master Production Records
  • Write/Review Standard Operating Procedures for manufacturing department
  • Perform routine internal audits of Manufacturing processes
  • Write and review protocols for development reports, IQ/OQ’s and validations

Job Requirements:

  • Associates/Bachelor’s degree in Chemistry, Biochemistry, or related discipline
  • 1-3  years of relevant experience
  • Experience with plasmid purification and microbiology techniques is preferred
  • Technical writing experience is a must to produce high-quality technical documentation including deviation and investigation reports,  SOP’s, and other supporting documentation
  • Bioprocessing and GMP experience is a plus
  • Computer proficient, especially with Microsoft Office products
  • Excellent communication skills and strict attention to detail

This is a temp to hire position with a Monday through Friday day shift work schedule and a pay rate of $20 per hour. If you meet the above qualifications, please submit your resume for immediate consideration.

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