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Biopharmaceutical Manufacturing Document Reviewer

Non-Headquarters

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

TECHNICAL WRITER

(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).
  • Emerson DeltaV and Honeywell BAS experience.
  • Customer-centric attitude and thrives off interaction with others.
  • Excellent client communication skills.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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