Technical Writer in Minneapolis, MN at DISYS

Date Posted: 6/14/2018

Job Snapshot

Job Description

TITLE                         - Technical Writer


LOCATION                 - Brooklyn park, MN


CONTRACT               - 12Months


 


RESPONSIBILITIES:


•        Attend cross-functional meetings (Validation, Manufacturing, Engineering, QC, QA) to capture/interview functional feedback for inclusion in technical documentation.


•        Interact with sample coordinators and/or QC lab to capture analytical data for inclusion in technical documentation.


•        Assist with review of executed technical protocols and/or test records for accuracy and compliance with Takeda’s validation program and Good Documentation Practices (GDP).


•        Utilize internal archives (electronic and paper) to research/cite supporting information for authoring and/or review of technical documents.


•        Review lab results for cleaning studies against protocol requirements and document results in cleaning development test records.


•        Facilitate cross-functional reviews, feedback, comment resolution, and approvals for technical documentation against program timelines.




REQIREMENTS:


•        Bachelor’s degree, or Associates degree with relevant technical writing experience is preferred.


•        2+ years of Pharmaceutical or Biologics manufacturing industry or regulated laboratory experience. Medical device experience may also be considered.


•        Must be able to clearly speak, write, read, and understand English. Including the ability to understand and verify scientific text and data.


•        Strong organizational skills, with the ability to handle multiple tasks.


•        Strong attention to detail.


•        Good oral and written communication skills, with the ability to interact appropriately with various groups including QA, QC, Technical operations, manufacturing and engineering.


•        Ability to work weekends as needed.


 


SKILLS:


•        Experience with data review and/or auditing in a GLP or GMP environment. Cleaning verification/validation experience in Biotech or Parenteral industry would be a plus.


•        Working knowledge of Biotech/Parenteral manufacturing, laboratory procedures, scientific testing standards, good documentation practices and concepts regarding validation and qualification.


•        The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.


•        An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Job Requirements

TITLE                         - Technical Writer


LOCATION                 - Brooklyn park, MN


CONTRACT               - 12Months


 


RESPONSIBILITIES:


•        Attend cross-functional meetings (Validation, Manufacturing, Engineering, QC, QA) to capture/interview functional feedback for inclusion in technical documentation.


•        Interact with sample coordinators and/or QC lab to capture analytical data for inclusion in technical documentation.


•        Assist with review of executed technical protocols and/or test records for accuracy and compliance with Takeda’s validation program and Good Documentation Practices (GDP).


•        Utilize internal archives (electronic and paper) to research/cite supporting information for authoring and/or review of technical documents.


•        Review lab results for cleaning studies against protocol requirements and document results in cleaning development test records.


•        Facilitate cross-functional reviews, feedback, comment resolution, and approvals for technical documentation against program timelines.




REQIREMENTS:


•        Bachelor’s degree, or Associates degree with relevant technical writing experience is preferred.


•        2+ years of Pharmaceutical or Biologics manufacturing industry or regulated laboratory experience. Medical device experience may also be considered.


•        Must be able to clearly speak, write, read, and understand English. Including the ability to understand and verify scientific text and data.


•        Strong organizational skills, with the ability to handle multiple tasks.


•        Strong attention to detail.


•        Good oral and written communication skills, with the ability to interact appropriately with various groups including QA, QC, Technical operations, manufacturing and engineering.


•        Ability to work weekends as needed.


 


SKILLS:


•        Experience with data review and/or auditing in a GLP or GMP environment. Cleaning verification/validation experience in Biotech or Parenteral industry would be a plus.


•        Working knowledge of Biotech/Parenteral manufacturing, laboratory procedures, scientific testing standards, good documentation practices and concepts regarding validation and qualification.


•        The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.


•        An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.