Technical Writer (Empower Exp Required) - BB4242
Job Description
Job Description
Technical Writer (Empower Exp Required) – BB4242
BB4242
Exton, PANA
12+ Months
Candidates from the last round of interviews were lacking the needed Empower experience. Empower experience was review-only or basic user.
- Required proficiency in configuration, creating methods, reports, and custom calculations.
- While not required, it would be a plus if this person had experience with validation of custom fields.
Candidates must be local and able to work onsite ~2-3 days per week. May be more, as needed. M-F 8-5 regular schedule.
Scientific background, ideally pharma experience
***Experience in Empower chromatographic data system REQUIRED
Job Qualifications
- BS in Chemistry, Biology or a related scientific discipline.
- At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
- Proficient in scientific/technical writing.
***Experience in Empower chromatographic data system
- Experience with LIMS, SAP/SRM, TrackWise, and Veeva.
- Excellent oral communication, interpersonal and technical writing skills.
- Excellent organizational skills, demonstrate attention to detail.
- Experience in GMP/GLP and/or a regulated industry.
- Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
- Advanced Excel knowledge is a plus.
Job Description
- Author technical reports, policies, and Standard Operating Procedures.
- Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
- Author investigations, deviations, change controls, and other non-conformance records.
- Work with vendors to coordinate testing and arrange shipments as needed.
- Compile and review scientific data for completeness as needed.
- Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
- Use of LIMS database including protocol setup, data entry/approval, and data trending.
- Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
- Coordinate document review, approval, and archiving.
- Participate in analytical testing lab activities, on an as needed basis.
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
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