Abbott Technical Writer in Waukegan, Illinois
DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives.
In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you
enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position is within our Abbott Rapid Diagnostics (ARDx) – Infectious Disease Emerging Markets. This job description will be reviewed periodically and is subject to change by management.
Responsible for assisting the ARDx manufacturing sites in writing documents related to the regulatory dossiers and preparing technical documents to support both domestic and international regulatory submissions for IDEM products.
Establishworking knowledge and application of a specialized technical skill.
Theprimary responsibility of the role is the creation of high-quality writtencontent to a pre-defined project timeline.
Requiredto create/ review/ edit/ update Quality and Technical Documents including, butnot limited to: SOPs, work/testing instructions, Validation Documentation,Design History Documentation including Design Inputs & Specifications,Verification Studies and Risk Management Dossiers.
Understandsand is aware of the quality consequences which may occur from the improperperformance of their specific job; has awareness of device defects that mayoccur in their area of responsibility, including product design, verificationand validation, manufacturing and testing activities.
Responsiblefor exhibiting professional behavior with both internal/external businessassociates that reflects positively on the company and is consistent with thecompany’s policies and practices; build productive internal/external workingrelationships.
Applyspecialized knowledge to coordinate day-to-day work.
Collaboratewith cross-functional global teams
Resolvemore complex situations by applying demonstrated knowledge and skills generallyacquired through job experience.
Analyzeinformation to select appropriate options from defined alternatives.
Applyexperience and judgment to make decisions or resolve issues within definedoptions or standard protocols.
Carriesout duties in compliance with established business policies.
Otherduties as assigned, according to the changing needs of the business.
Independentlygather resources and information needed to complete projects.
BASIC QUALIFICATIONS | EDUCATION:
Minimumof a Bachelors’ Degree (BA/BS) from an accredited University
Minimumof 5 years of experience in a GMP / Biotech / Pharma / Medical Device/ IVD/ RegulatedIndustry.
PREFERRED QUALIFICATIONS ANDCOMPETENCIES:
Strongwritten and verbal communication skills
Demonstratedsuccess in Technical Writing in the GMP / Biotech / Pharma / RegulatedIndustry.
Abilityto adapt quickly and effectively to shifting priorities.
Verystrong attention to detail
Mustbe coachable and must follow written and verbal direction
Mustbe able to productively generate quality documentation to meet Programtimelines
Flexiblescheduling (if needed and advance notice is given)
Strongskills in Microsoft Office, especially in Word, Excel, and PowerPoint
Generalknowledge of Quality/Regulatory requirements in a medical device/ pharma/biotech industry
Adaptability,Innovation, Initiative, Teamwork, Quality of Work, Commitment
An equal opportunityemployer, Abbott welcomes and encourages diversity in our workforce.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org