GMP TRAINER

(BIOTECHNOLOGY R&D / MANUFACTURING)

Do you…

• Enjoy working in a team environment and driving activities?
• Believe in the value of being customer-service oriented, accurate and delivering quality support to stakeholders in an organization?
• Have a passion for technology, data and efficiency of IT solutions?

If so, Valspec may have a great opportunity for you to join one of our client site-based teams in the Philadelphia Suburbs.

Due to continued expansion of long-term support services we provide to major biotechnology organizations we are looking to add industry knowledgeable professionals to one of our groups. In this customer-centric role you will become a subject matter expert with documentation/data systems and their associated quality standards. As a hands-on specialist you will assist, guide and ensure that standards are being met and processes are followed. The successful candidate will have a genuine interest in science, technology and the opportunity to gain exposure to biotechnology research and manufacturing. Primary day-to-day involvement would include, but not be limited to:

• Utilizing a Controlled Document Management System (CDMS)
• Perform document compliance editing checks on many forms of controlled documents (SOPs, Instructions, Material Specifications, Analytical Methods, Validation Protocols, etc.) prior to sending for review and approval.
• Assist Authors in creating documents and workflows in CDMS
• Assist Authors with the use of Microsoft Word advanced functionality (styles, cross-references, tables, pictures, embedded objects, etc.)
• Ensure that documents render properly in CDMS and troubleshoot any rendering issues
• Ensure that the appropriate reviewers and approvers are assigned to documents
• Maintain organization and attention to detail in a fast-paced workflow environment

Requirements

• 2 years of Document/Data Control Management experience within a Life Sciences/Biotechnology/Pharmaceutical R&D and/or Manufacturing Environment.
• Bachelor’s Degree in Biology or relevant Sciences Degree.
• Possess a solid foundation and understanding of quality systems and an understanding of cGMP requirements is essential.
• Hands-on experience with CDMS (Controlled Document Management Systems)
• Customer-centric attitude and thrives off interaction with others.
• Excellent client communication skills.