QC Technical Writer
Proclinical is currently recruiting for a Quality Control Technical Writer for a pharmaceutical company located in Philadelphia, PA. Successful candidate will write, review, revise and maintain analytical technical documents within the Quality Control Laboratory. The Technical documents include, but are not limited to; Testing Methods, Specifications, Standard Operating Procedures, Technical Transfer Documents, Method Validation, Verification protocols and reports.
- Write, review and revise the following documents: Analytical Methods and Specifications; Pre and Post approval Stability protocols; Method Validation, Verification, Transfer, and Experimental Protocols and Reports; SOPs pertaining to laboratory equipment and operation; Forms, checklists, and training quizzes associated with SOPs
- Initiates change controls for analytical document implementations and revisions
- Perform GMP technical data review for analytical activities such as; but not limited to; method validation, method transfer, method verification and testing of Stability Submission batches
- Support laboratory investigations including, identification of root cause, identification and implementation of appropriate corrective and preventative actions, authoring the final investigation report, and writing the impact assessments
- Providing quality and technical support to Laboratory Manager, Group Leaders, as well as Scientist and Laboratory Technicians
- Support key projects for Laboratory Operations aimed at elevating compliance
- Maintain periodic review of Laboratory SOPs
Skills and Requirements:
- Bachelor's degree or higher in Science Field, Chemistry Degree preferred.
- Three or more years of demonstrated excellence in the field of analytical chemistry.
- Three or more years of experience in writing analytical technical documents.
- Experience troubleshooting Laboratory Deviations.
- Knowledge of cGMP and related compliance regulation and guidance is required.
- Prior experience in a pharmaceutical (cGMP) laboratory setting is required.
- Knowledge of FDA/ICH guidelines with respect to FDA's current requirements for method validation, verification, transfer, and stability.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.