Technical Writer - Integrated Resources, Inc
West Hills, CA 91304
About the Job
M-F 8am-5pm. 100% on Site
Job Description: The Technical Operations team is responsible for process validations, technical transfer and
technical support for reagents, test kits and instrument assembly. This team is critical as TDX
implements continuous improvement throughout our facilities and processes.
The Technical Writer will work closely with Operations, Engineering, Quality and Research &
Development for the writing, editing, and producing protocols, procedures and other relevant
technical and functional documentation to support Process Automation, Equipment Installations,
Procedural updates, etc. The documentation the Technical Writer will develop and deliver can
include but not be limited to User Requirement Specifications (URS), Design Qualification (DQ),
installation qualification (IQ), operational qualification (OQ), performance qualification (PQ),
cleaning validation, process validation and operations procedures in support of the equipment,
products and processes at TDX. This person must have excellent research skills, must be able to
organize his/her ideas, and be able to translate technical terms into text that any reader can
understand.
Key Responsibilities:
"Develop high-quality scientific/technical documentation for end users from information
and data provided by R&D scientists, operations managers, and other key business team
members.
"Synthesize and organize the information in a logical and concise way that meets the
needs of our target audience.
Proactively solicit information from other experts within the company as needed (e.g.,
operations excellence, tech support, quality, engineering, and legal).
"Attend team meetings and interact with subject experts on a daily basis.
"Manage multiple projects with multiple deliverables simultaneously, while working
independently and with other members. Deliver under tight deadlines.
"Follow all processes, style guides, templates, brand guidelines and terminology.
"Identify and suggest improvements to processes and deliverables.
"Identify and communicate risks to project deadlines in advance.
"Solicit and incorporate feedback from internal and external customers to improve
document quality.
"Work with minimal supervision and manage time effectively.
"Lead departmental special projects as needed.
"Write and review protocols and reports.
"Works with Operations Excellence, Operations & Quality to drive efficiency and
implement future state processes.
"Participant in our PPI Lean Enterprise initiatives driving improvements through customer
delivery & improved quality, as well as cost reduction/avoidance to drive growth and
improve profitability.
"Completes process validations.
"Promote a collaborative Team environment that fosters creativity, innovation and high
performance.
Minimum Requirements/Qualifications:
" Bachelor s degree in a scientific discipline.
" An advanced degree such as an MBA is a plus. PM certification is a plus.
" 3 5 years of technical writing experience, preferred in medical device or pharmaceutical
arena.
" Thorough understanding of technical/scientific content. Keen attention to detail and high
regard for quality.
" Can effectively adapt structure, tone, and style to meet needs of business.
" Excellent verbal and written communication skills.
" Demonstrated knowledge of commonly used concepts, practices, and procedures within
the field of technical writing.
" Consistently demonstrated validation proficiency, with knowledge of equipment
qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation
systems.
" Strong project management and organizational skills.
" Possess a continuous process improvement mindset with the ability to effectively lead
and manage change.
" Proficient in use of Microsoft Office Suite.
" Must be able to travel as needed.
" Performs all job duties in a safe manner, consistent with the Code of Ethics and the
*** 4-I core values of Integrity, Intensity, Innovation, and
Involvement.
" Performs other duties as assigned.
Job Description: The Technical Operations team is responsible for process validations, technical transfer and
technical support for reagents, test kits and instrument assembly. This team is critical as TDX
implements continuous improvement throughout our facilities and processes.
The Technical Writer will work closely with Operations, Engineering, Quality and Research &
Development for the writing, editing, and producing protocols, procedures and other relevant
technical and functional documentation to support Process Automation, Equipment Installations,
Procedural updates, etc. The documentation the Technical Writer will develop and deliver can
include but not be limited to User Requirement Specifications (URS), Design Qualification (DQ),
installation qualification (IQ), operational qualification (OQ), performance qualification (PQ),
cleaning validation, process validation and operations procedures in support of the equipment,
products and processes at TDX. This person must have excellent research skills, must be able to
organize his/her ideas, and be able to translate technical terms into text that any reader can
understand.
Key Responsibilities:
"Develop high-quality scientific/technical documentation for end users from information
and data provided by R&D scientists, operations managers, and other key business team
members.
"Synthesize and organize the information in a logical and concise way that meets the
needs of our target audience.
Proactively solicit information from other experts within the company as needed (e.g.,
operations excellence, tech support, quality, engineering, and legal).
"Attend team meetings and interact with subject experts on a daily basis.
"Manage multiple projects with multiple deliverables simultaneously, while working
independently and with other members. Deliver under tight deadlines.
"Follow all processes, style guides, templates, brand guidelines and terminology.
"Identify and suggest improvements to processes and deliverables.
"Identify and communicate risks to project deadlines in advance.
"Solicit and incorporate feedback from internal and external customers to improve
document quality.
"Work with minimal supervision and manage time effectively.
"Lead departmental special projects as needed.
"Write and review protocols and reports.
"Works with Operations Excellence, Operations & Quality to drive efficiency and
implement future state processes.
"Participant in our PPI Lean Enterprise initiatives driving improvements through customer
delivery & improved quality, as well as cost reduction/avoidance to drive growth and
improve profitability.
"Completes process validations.
"Promote a collaborative Team environment that fosters creativity, innovation and high
performance.
Minimum Requirements/Qualifications:
" Bachelor s degree in a scientific discipline.
" An advanced degree such as an MBA is a plus. PM certification is a plus.
" 3 5 years of technical writing experience, preferred in medical device or pharmaceutical
arena.
" Thorough understanding of technical/scientific content. Keen attention to detail and high
regard for quality.
" Can effectively adapt structure, tone, and style to meet needs of business.
" Excellent verbal and written communication skills.
" Demonstrated knowledge of commonly used concepts, practices, and procedures within
the field of technical writing.
" Consistently demonstrated validation proficiency, with knowledge of equipment
qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation
systems.
" Strong project management and organizational skills.
" Possess a continuous process improvement mindset with the ability to effectively lead
and manage change.
" Proficient in use of Microsoft Office Suite.
" Must be able to travel as needed.
" Performs all job duties in a safe manner, consistent with the Code of Ethics and the
*** 4-I core values of Integrity, Intensity, Innovation, and
Involvement.
" Performs other duties as assigned.
Source : Integrated Resources, Inc