Our client located in Spring Valley, NY is in need of a Technical Writer for a long term contract position.
Pay Range: $36-$38/hr
Location: Spring Valley, NY
Industry: Pharmaceutical
Start: ASAP
Technical Writing Responsibilities:
•Together with appropriate internal development groups (QC, R&D, Regulatory Affairs), prepare, track, upkeep and audit technical specifications and procedures (Monograph).
•Review USP/NF, USP/NF Supplements and Pharmacopeial Forum, and circulate the latest supplements for review by the PF/USP Committee. Solicit feedback from Scientists on relevant monographs which may have impact on client test methods and procedures. Implement feedback by either updating monographs or engaging in dialogue with the PF or USP on proposed changes. Ensure changes and procedures are in compliance.
•Prepare documentation for submission to the USP.
•Maintain a comprehensive documentation issuance and control system.
•Assign, track, and archive laboratory notebooks.
•Input tracking information into Technical Documentation Databases to maintain an accurate record of revisions to Monographs.
•Provide documentation to the Regulatory Affairs group in the course of assembling new product ANDAs for submission to the FDA.
•Assist in duties related to Change Control
•Knowledge of cGMPs
Education and/or Experience
Bachelor’s Degree or equivalent with 5-7 years work experience or an equivalent overall level of knowledge based upon previous work experience.
To perform this job successfully, an individual should have:
•Familiarity with GMP regulations, compliance issues, and USP/NF and PF publications and terminologies.
•Strong work ethic, focused, able to prioritize workload with minimal supervision, detailed oriented, along with organization skills, able to multi-task and follow-up on open tasks. Importantly the ability to execute on job functions in timely manner.
•Excellent verbal and written communication skills
•The ability to work with individual in a professional manner up down the organizational ladder.
•Proficiency in the following software applications: Microsoft Office, Access Database, Excel, Trackwise, JD Edwards, Adobe Acrobat Professional and Score
•The ability to master new applications upon request.
Candidates will submit their resume for immediate consideration to Jennifer:
JCremonesi@volt.com
EOE
Pay Range: $36-$38/hr
Location: Spring Valley, NY
Industry: Pharmaceutical
Start: ASAP
Technical Writing Responsibilities:
•Together with appropriate internal development groups (QC, R&D, Regulatory Affairs), prepare, track, upkeep and audit technical specifications and procedures (Monograph).
•Review USP/NF, USP/NF Supplements and Pharmacopeial Forum, and circulate the latest supplements for review by the PF/USP Committee. Solicit feedback from Scientists on relevant monographs which may have impact on client test methods and procedures. Implement feedback by either updating monographs or engaging in dialogue with the PF or USP on proposed changes. Ensure changes and procedures are in compliance.
•Prepare documentation for submission to the USP.
•Maintain a comprehensive documentation issuance and control system.
•Assign, track, and archive laboratory notebooks.
•Input tracking information into Technical Documentation Databases to maintain an accurate record of revisions to Monographs.
•Provide documentation to the Regulatory Affairs group in the course of assembling new product ANDAs for submission to the FDA.
•Assist in duties related to Change Control
•Knowledge of cGMPs
Education and/or Experience
Bachelor’s Degree or equivalent with 5-7 years work experience or an equivalent overall level of knowledge based upon previous work experience.
To perform this job successfully, an individual should have:
•Familiarity with GMP regulations, compliance issues, and USP/NF and PF publications and terminologies.
•Strong work ethic, focused, able to prioritize workload with minimal supervision, detailed oriented, along with organization skills, able to multi-task and follow-up on open tasks. Importantly the ability to execute on job functions in timely manner.
•Excellent verbal and written communication skills
•The ability to work with individual in a professional manner up down the organizational ladder.
•Proficiency in the following software applications: Microsoft Office, Access Database, Excel, Trackwise, JD Edwards, Adobe Acrobat Professional and Score
•The ability to master new applications upon request.
Candidates will submit their resume for immediate consideration to Jennifer:
JCremonesi@volt.com
EOE