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Technical Writer, Analytical Outsourcing, Biopharmaceutical Development
210 Welsh Pool Rd Franklin Ctr, PA 19341 US
Job Description
Target Pay Rate: 30-38.66/hr **salary will be commensurate with experience
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.
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.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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