The Document Control Specialist oversees the revision, issuance and tracking of controlled documents used to support manufacture of plasmid DNA (pDNA) at our client's site. The individual is a mature professional capable of working independently and in a team setting. The individual continually evaluates opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. The individual requires the ability to produce results in a fast-paced environment to meet deadlines and to effectively prioritize responsibilities based on criticality.
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Responsibilities:
Manage the eQMS (MasterControl) and the Document Control Files for The Woodlands site
Document Change Control
Responsible for processing, distributing, and maintaining controlled documentation (i.e., paper-based Batch Records, SOPs, material specifications, logbooks, etc.) using a document control system
Work directly with Subject Matter Experts to define documentation requirements
Maintain archived records according to company and regulatory policies
Editing of documents in accordance with formatting and template requirements
Work as part of a cross-functional team to implement new Quality Systems
Working hours: 8:00 AM - 5:00 PM
Skills:
High level proficiency with MasterControl strongly preferred
Education:
Bachelors
Experience:
4-7 years
Qualifications:
BS/BA in a life science or an equivalent combination of education, experience, and training
6+ years of experience working with MasterControl in a biotechnology or pharmaceutical industry
2+ years of experience with implementing Quality Systems
Strong attention to detail. Completes tasks in a thorough and effective manner. Ability to multitask and work independently. Expert knowledge of Windows systems (Word, Excel, PP)
Apply now!
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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).