0170 Technical Writer
The Technical Writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling the production of those drugs for the commercial market.
These individuals build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our drugs to patients.
Provide technical and cGMP expertise for all aspects of technical writing and testing documents.
May contribute to QC data review and/or verification in support of method studies.
Provide technical expertise for all aspects of testing, method validation, transfer, and lifecycle management.
Coach and develop individuals within the group.
Responsible for inter-team and inter-department.
Collaboration with QC Analysts, Associates, Scientists, Laboratory managers to ensure successful QC Laboratory studies and method implementation.
Develop and maintain both internal and external relationships.
Contributes to authorship of regulatory submissions; presents work to cross-functional teams as required.
Author, review, and approve documents such as standard operating procedures, protocols, reports, master plans, policies, and investigation or change request records.
Interact with development laboratories and provide guidance for qualification and transfer of methods.
Ensure the team is compliant with GXP and safety and environmental standards.
Participate and ensure support for cross-functional teams.
Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
Lead and implement initiatives that add value to the QC and global operations.
Interpret and apply 21CFR, USP, EP, JP, and ICH regulatory guidelines and directives.
Other job responsibilities as assigned.
Minimum 3 years of experience in Quality Control or similar environment.
Sound knowledge of ICH and FDA guidance documents for analytical methods.
Proven technical writing experience.
Proficiency with Trackwise or QMS and Office365 preferred.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.