Technical Writer
Job Responsibilities:
- 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 lab activities, on an as needed basis.
Skills:
- Proficiency in Scientific Writing/Technical Writing,
- Experience in Empower chromatographic data system,
- Experience with LIMS, SAP/SRM, Track Wise, and Veeva,
- Experience in GMP/GLP and/or a regulated industry.
Education/Experience:
- 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, Track Wise, 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.
- BS in Chemistry, Biology or a related scientific discipline.
Recommended Jobs
14384 - Director of Clinical Services - Hybrid- Southeast, PA
Together we change lives . Kelly is a team of experts driven by our belief that the impact of the right person in the right job is limitless. No matter where you are in your career journey,…
Diesel Mechanic Needed for Growing Dealership
Job Description Job Description Bowser Automotive in Pleasant Hills is seeking a Diesel Service Technician. The Diesel Tech is responsible for repairs, inspection and maintenance of diesel ve…
Mechanic
Job Description Job Description Do you have the need for speed? Do you thrive in a fast paced, energetic work environment that focuses on serving our customers? If so, K1 Speed is the place for…
Sheet Metal Installer and Mechanic
Job Description Job Description Benefits: ~ Employee Assistance Program ~ Training & development ~ Tuition assistance ~ Vision insurance ~ Wellness resources ~401(k) ~ Competitive sa…
Med Tech
Job Description Job Description Description: POSITION TITLE: MEDICATION TECHNICIAN DEPARTMENT: Clinical Services REPORTS TO: Resident Care Director POSITION SUMMARY: The essential …
Truck Driver Class A CDL Dedicated
SWIFT DEDICATED REFRIGERATED OPPORTUNITY Out of Leesport, PA HOME WEEKLY! Advantages of Swift Dedicated Refrigerated Fleet Interested in driving with Swift Refrigerated? Please text SWIFTCAREER …
Director of Operations - Envera
Job Description Job Description Company Description SUMMARY: For over 170 years, Lesaffre has been a pioneering force in the world of fermentation, harnessing the power of microorganisms …
Bank Teller
Job Description Job Description Financial Services Representative (FSR) – West Side Office Location: West Side Office – 1100 Lincoln Way West, Chambersburg, PA 17202 Join a Community Bank That…
Truck Driver -Office Furniture Installer
Job Description Job Description Description: JOB SUMMARY: Deliver office furniture in our 26' Box truck. Install product under the direction of the Foreman per manufacturer’s specificat…
Senior Manager Reliability Engineering
Job Description Job Description Overview Mural Group is partnering with a multi-site industrial manufacturer to hire a Corporate Reliability Engineering Manager. This role is responsible fo…