The company is looking to solve the problem of documenting Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control, in a cGMP compliant manner.
Requirements
- Proficient with MS Office Applications
- Experience with HPLC, Dionex, GC, LCMS, UVVis Spectroscopy and empower software
- Familiarity with 21CFR part 11 validation automation systems is required.
- Able to train on and follow company SOP documentation standards, templates and practices.
- Work in compliance with cGMPs.
- Experience with cGXP compliance in all documentation.
- Experience with Laboratory Equipment Qualification (IQ, OQ, and PQ)
Responsibilities
- Prepare drafts of the protocol and technical report documentation for review with subject matter experts, project staff and/or customers.
- Edit, standardize, or revise material prepared by other writers or subject matter experts.
- Create and revise protocols and technical reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) with input from subject matter experts and according to company policies.
- Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification
- Prepare binders containing all relevant documentation. Organize documentation and cross-reference documents as necessary.
- Route final documents for the appropriate approvals.
- Investigate and document non-conformances in a timely manner.
Other
- Bachelor's degree with 6-9 years in biopharmaceuticals or Life Sciences OR Master's degree with 4-7 years in biopharmaceuticals or Life Sciences
- Excellent writing and editing skills and must write in a concise and easy-to-read manner
- Work independently under minimal supervision and direction.
- Work effectively across organizational and functional boundaries
- 2 years experience working in cGMP environment
