Technical Writer

Abbott ,
Dundee, City of Dundee
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Overview

Job Description

**RESPONSIBILITIES:** + Directlyparticipate in a Quality Systems Improvement Program for an _in-vitro_ diagnostics manufacturingfacility with a Quality Management System certified to ISO13485. + The primaryresponsibility of the role is the creation of high-quality written content to apre-defined project timeline. + Required tocreate/ review/ edit/ update Quality and Technical Documents including, but notlimited to: SOPs, work/testing instructions, Validation Documentation (IQ / OQ/ PQ), Design History Documentation including Design Inputs &Specifications, Verification Studies and Risk Management Dossiers. + Understands andis 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. + Responsible forexhibiting professional behaviour 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. + Carries outduties in compliance with established business policies. + Other duties asassigned, according to the changing needs of the business. **MINIMUMQUALIFICATIONS | EDUCATION/EXPERIENCE:** + Minimum of a Bachelor'sDegree (BA/BS) from an accredited University + Minimum of 3years of experience in a GMP / Biotech / Pharma / Regulated Industry **PREFERREDQUALIFICATIONS:** + Demonstratedsuccess in Technical Writing in the GMP / Biotech / Pharma / Regulated Industry. + Very strongwritten and verbal communication skillsStrong skills in Microsoft Office, especially inWord, Excel, and Powerpoint. + Generalknowledge of Quality/Regulatory requirements in a medical device/ pharma/biotech industry. **COMPETENCIES:** + Very strongattention to detail + Must becoachable and must follow written and verbal direction + Must be able toproductively generate quality documentation to meet Program timelines 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 corpjat@abbott.com

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