Technical Writer
Spectraforce
West Point, Pennsylvania
4 hours ago
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.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 43.00/hr.
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.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 43.00/hr.