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INCOG BioPharma Services · 1 month ago

Deviation Writer

Fishers, IN

Full-time

Onsite

Mid Level

3+ years exp

INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating complex technical events into clear investigations and requires collaboration with cross-functional teams to support effective corrective actions and preventative measures.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts

Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause

Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc

Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes

Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups

Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner

Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends

Qualification

GMP knowledgeRoot cause analysisTechnical writingElectronic Quality Management SystemsMicrosoft Office proficiencyInterpersonal skillsOrganizational skillsCollaboration skills

Required

Bachelor's degree in a scientific, engineering, or technical discipline

Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries

Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts

Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause

Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc

Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes

Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups

Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner

Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends

Preferred

Proficient in writing clear, concise, and accurate technical documentation

Strong understanding of GMP manufacturing processes and regulatory requirements

Excellent organizational skills with high attention to detail

Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences

Familiarity with documentation tools and electronic document management systems (EDMS)

Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees