This position is responsible for documenting Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control.
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.
Revisions of Laboratory Equipment Qualification documentation must be done utilizing defined content and formatting requirements. Ensure cGXP compliance in all documentation.
Investigate and document non-conformances in a timely manner.
Able train on and follow company SOP documentation standards, templates and practices.
Work in compliance with cGMPs.
Additional Responsibilities
Incorporate new material or information while understanding its implications.
Work independently under minimal supervision and direction.
Work effectively across organizational and functional boundaries
Skills:.
Excellent writing and editing skills and must write in a concise and easy-to-read manner
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.
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
2 years experience working in cGMP environment
Regards,
Akriti Gupta
Associate Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3409 | Fax: 973.998.2599
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Job details are sourced from the employer's original posting.
Open job postingAbout the company
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com