job summary: **Urgent Need
for a Technical Writer
to join the Technical Services Team. This person should have 2-5 years of technical writing experience.**
location: Allentown, Pennsylvania
job type: Permanent
salary: $65,000 - 75,000 per year
work hours: 9 to 5
- Interact with technical associates/scientists/leads from Technical Services, Product Development and other departments to create product development reports, validation protocols and reports, development and GMP Batch Records (solid, semisolid and liquids dosage forms), investigations, CAPAs, change controls, scale up documents, etc. with a strong emphasis on the following pharmaceutical processes (blending, granulation, milling, fluid bed granulation/drying, single and bi-layer compression, encapsulation, coating, and packaging).
- Responsible to oversee and own the control of document templates to assure cGMP and document standards are maintained and consistent across processes.
- Update and revise batch records, protocols, and all IQ/OQ/PQ templates to remove redundancies, improve compliance and to ensure that documents are user friendly and clear.
- Support the department Head for process validation activities.
- Prepare, write, update and maintain divisional/departmental SOPs where applicable, including the preparation of any forms or attachments that may accompany the SOP.
- Ability to research and understand the new equipment through user manuals to create SOP, IQ/OQ/PQ documents for equipment qualification program.
- Ability to write documents for eCTD filling as per FDA guidance.
- Other duties as assigned.
- Degree (BA/BS) in a technology related field (Biology, Chemistry, Pharmacy, Engineering, etc.) and at least 2-7 years of product development and/or manufacturing experience in a cGMP manufacturing environment with the ability to understand the fundamental processing stages required to create the initial batch records as well as other supporting documentation (i.e. protocols, change controls, investigations, deviations and final reports).
- 2-5 years of technical writing experience.
skills: SOP, CAPA, IQ, OQ, PQ, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.