Manufacturing Technical Writer

Simtra BioPharma Solutions•Bloomington, IN

62d•Onsite

About The Position

The Manufacturing Technical Writer is responsible for performing site Non-Conformance Report (NCR) and Significant SNCRs investigations, utilizing investigative tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions and related effectiveness criteria. Personnel filling this role will be the primary investigator for the NCR and SNCRs for the entire Bloomington facility. This candidate will sit onsite at the Bloomington facility and report to the Sr. Manager, Technical Services.

Requirements

BS degree required, preferably in a science or technical area or equivalent experience
2+ years technical writing experience, preferably in pharmaceutical industry
Knowledge of applicable CAPA procedures, specifications, regulations and standards
Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
Goal-setting, prioritize, organization, attention to detail, and time management skills
Critical & creative thinking and problem-solving skills
Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
Strong oral and written communication skills
Ability to demonstrate strong leadership skills
Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
Ability to utilize enterprise software systems (Trackwise)
Duties will require overtime work, including nights and weekends on occasion
Ability to gown in C/D gowning area

Responsibilities

Develop the scope and devise an approach for assigned investigations
Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
Identify cross-functional team members and assemble the investigation team
Confirm corrections/containment identified based on the investigation results
Determine the appropriate data sources to be evaluated for the investigation and obtain the required data
Investigate the root cause(s) of the issue and document the investigation results
Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan
Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
Manage multiple investigations at any given time
Responsible for speaking to client auditors and regulatory authorities to explain investigations