Technical Writer III at Artech LLC
Andover, MA 01810
About the Job
I'm a recruiting consultant with Artech and I'm hoping I can help you find the perfect next opportunity for your career goals. You very well could be happy in your present role but might be looking for a more challenging project or maybe you want to explore opportunities outside your comfort zone. I am currently recruiting for a Technical Writer III for one of the largest Pharmaceutical companies in the US. Below are the specs for the role: -
Job Description
Job Title: - Technical Writer III
Job Duration: - 6+ Months
Job Location: - Andover, MA
Job Description for Quality Control (QC) Tech Transfer Contractor Quality Control
This role will provide non-testing support to the QC Analytical department for technology transfer activities. This scope includes coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between Client sites. The technical skills within scope will require understanding of the scientific principles of test methods, data analysis and cGMP requirement. The candidate will be responsible for facilitating tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at Client. The key responsibilities of the candidate are as follows:
• Authoring method transfer documents using Client document workflow, through collaboration with SMEs
• Supporting lab testing by reviewing data and documents for accuracy and compliance.
• Supporting assay remediation activities and generating supporting documents.
• Participating in across site tech transfer meeting and tracking the project timeline
• Supporting sample/resource request and coordinating sample shipment and documentation
• Communicating with receiving laboratory and supporting gap assessment, sample request and queries
Successful candidate requires:
• Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP<1224>.
• Scientific background in analytical methods, including HPLC, iCE, CGE, ELISA and bioassay.
• Knowledge of QC analytical support and technical writing
• Strong interpersonal and written communication skills.
• A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation.
• A BS with over 5-year experience, MS over 3-year experience or PhD degree in biochemistry and analytical chemistry
• Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required.
Click "APPLY” to send your resume for this role or you can send an email to me at Sameer.Tiwari@artech.com . You can also reach me directly at 973-933-4899
Artech has been an employer-of-choice for 27 years, proudly serving over 80 Fortune 500 companies. We have dedicated professionals that will help you with your next career move. Our recruiters will listen carefully to your career goals and then match your skills and aspirations to various open roles. There is nothing we are more passionate about than finding candidates a rewarding job that makes them happy. Artech is an EEO Employer.
Job Description
Job Title: - Technical Writer III
Job Duration: - 6+ Months
Job Location: - Andover, MA
Job Description for Quality Control (QC) Tech Transfer Contractor Quality Control
This role will provide non-testing support to the QC Analytical department for technology transfer activities. This scope includes coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between Client sites. The technical skills within scope will require understanding of the scientific principles of test methods, data analysis and cGMP requirement. The candidate will be responsible for facilitating tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at Client. The key responsibilities of the candidate are as follows:
• Authoring method transfer documents using Client document workflow, through collaboration with SMEs
• Supporting lab testing by reviewing data and documents for accuracy and compliance.
• Supporting assay remediation activities and generating supporting documents.
• Participating in across site tech transfer meeting and tracking the project timeline
• Supporting sample/resource request and coordinating sample shipment and documentation
• Communicating with receiving laboratory and supporting gap assessment, sample request and queries
Successful candidate requires:
• Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP<1224>.
• Scientific background in analytical methods, including HPLC, iCE, CGE, ELISA and bioassay.
• Knowledge of QC analytical support and technical writing
• Strong interpersonal and written communication skills.
• A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation.
• A BS with over 5-year experience, MS over 3-year experience or PhD degree in biochemistry and analytical chemistry
• Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required.
Click "APPLY” to send your resume for this role or you can send an email to me at Sameer.Tiwari@artech.com . You can also reach me directly at 973-933-4899
Artech has been an employer-of-choice for 27 years, proudly serving over 80 Fortune 500 companies. We have dedicated professionals that will help you with your next career move. Our recruiters will listen carefully to your career goals and then match your skills and aspirations to various open roles. There is nothing we are more passionate about than finding candidates a rewarding job that makes them happy. Artech is an EEO Employer.