Technical Writer Job at LanceSoft, Inc. in Longmont

bachelor’s in science, Engineering, or similar.

The successful candidate will have at least 2-4 years of GMP Pharma experience

-Strong technical writing abilities

-Experience in root cause analysis and CAPA development

The Manufacturing Operations Investigator / Technical Writer provides technical writing and compliance expertise and will be responsible for the following activities:

• Lead investigation activities by gathering information from internal and external sources to resolve root cause, evaluate product and equipment impact, evaluate risk to previous or future batches and develop effective CAPAs.
• Author comprehensive investigation reports
• Author and revise technical documentation including facility and equipment SOPs.
• Author and manage change controls and CAPAs.
• Participate in customer and regulatory meetings.

Essential Duties & Responsibilities:

Deviation Investigation and CAPA:

• Thoroughly investigate deviation events utilizing root cause analysis techniques. Utilizes technical writing strategies to ensure content is clear, concise, and complete. Lead team to evaluate pertinent aspects involved in resolving deviation scope, root cause and impact. Identify necessary CAPAs to address root cause and contributing causes discovered during investigation.

Document Revisions:

• Write and manage change SOPs to facilitate improvements driven by the deviation, CAPA and compliance inspection systems.

Customer and Regulatory Support:

• Responsible for maintaining compliance and inspection readiness within the Operations department in the following ways:
• Complete deviations, CAPAs, document revisions and training activities to meet quality system requirements and timelines.
• Represent deviations and CAPA during customer meetings and customer inspections.