6 Month CONTRACT role. ONSITE in Swiftwater, PA. Local candidates highly preferred. Minimum BS degree though MS and PhD welcomed. REQUIRED-2+ years of GMP Technical Documentation experience as well as LIMS/iLMS experience. Pay rate range $45.00-$50.00/hour.

Lenox Executive Search is seeking an experienced GMP Quality Technical Documentation Specialist to fill an 6 month contractual role with a global pharmaceutical company in Swiftwater, PA. Must have GXP and LIMS/iLMS experience.

REQUIREMENTS for the GMP LIMS Technical Documentation Specialist:

• Bachelor's Degree required. MS & PhD welcomed
• 2+ years of relevant GxP Technical Writing experience
• MUST HAVE prior experience with quality applications, such as Veeva, LIMS, iLMS
• Experience creating creating Training slides and content
• Prior experience with MS Word, Excel, PowerPoint, Visio and Outlook
• Qualipso experience a big plus
• Sequel a big plus
• Continuous Processs Verification (CPV) experience a big plus
• Prior work experience in a good manufacturing practices (GMP) environment
• Must possess sound interpersonal and information gathering skills, be able to relate well to others and have the ability to work in a team environment, effectively interacting with others
• Excellent verbal and written communication skills.

RESPONSIBILITIES of the GMP LIMS Technical Documentation Specialist:

• Supporting on-time implementation of OneLIMS EM global system for the Swiftwater, PA site.
• Perform tasks in an efficient, cGMP compliant, and safe manner.
• Must be adaptable and react quickly to changing priorities in a high-stress environment.
• Alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMs
• Design, develop, and update required technical documentation
• Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements
• Create Training slides and content
• Support Future state process mapping
• Organize, track and plan master data review
• Track and mange project specific deliverables

Pay: $45.00 - $50.00 per hour

Education:

• Bachelor's (Required)

Experience:

• GxP Technical Writing: 2 years (Required)
• Quality Document editing: 2 years (Required)
• Biotech Pharma industry: 1 year (Preferred)
• Qualipso: 1 year (Preferred)
• Sequel: 1 year (Preferred)
• Continuous Process Verification (CPV): 1 year (Preferred)
• LIMS/iLMS : 1 year (Required)

Ability to Commute:

• Swiftwater, PA 18370 (Required)

Work Location: In person