Technical Writer
Job Description
Technical Writer
12 motnhs
Remote opportunity.
Work location: WestPoint, PA is an option for candidate who are local and want to work from office(hybrid).
Summary
We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.
* The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
* The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Primary Responsibilities:
* Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
* Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
* Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
* Collaborate closely with key stakeholders.
Education:
* Minimum qualification- BS/BA in life sciences/engineering is required
* Master's degree/PHD preferred
Required Experience and Skills:
* At least 2 years working experience in a cGMP laboratory environment.
* Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
* Strong oral and written communication skills.
* Work independently and within cross-functional teams.
* Maintain a proactive and service-oriented mindset.
* Experience with MS Office and document repository systems.
Preferred Experience and Skills:
* Experience with analytical method validation and transfer according to ICH and USP guidelines.
* Experience with laboratory data management systems
Software skills: MS office suite
Personality:
* Detail oriented
* Excellent writing skills
* Collaborative
* Good communication and interpersonal skills.
12 motnhs
Remote opportunity.
Work location: WestPoint, PA is an option for candidate who are local and want to work from office(hybrid).
Summary
We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.
* The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
* The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Primary Responsibilities:
* Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
* Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
* Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
* Collaborate closely with key stakeholders.
Education:
* Minimum qualification- BS/BA in life sciences/engineering is required
* Master's degree/PHD preferred
Required Experience and Skills:
* At least 2 years working experience in a cGMP laboratory environment.
* Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
* Strong oral and written communication skills.
* Work independently and within cross-functional teams.
* Maintain a proactive and service-oriented mindset.
* Experience with MS Office and document repository systems.
Preferred Experience and Skills:
* Experience with analytical method validation and transfer according to ICH and USP guidelines.
* Experience with laboratory data management systems
Software skills: MS office suite
Personality:
* Detail oriented
* Excellent writing skills
* Collaborative
* Good communication and interpersonal skills.