What are the responsibilities and job description for the GMP LIMS Technical Documentation Specialist position at Lenox Executive Search?
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
Salary : $45 - $50