Technical Writer

The QC Technical Writer is a critical position on AG’s high-performing Quality team that will be responsible for supporting Quality, Supply Chain, and Manufacturing with Investigations of Deviations, Complaints, Out-of-Specification and Out-of-Trend results, and Change Controls. This position is required to be on-site at AG’s QC lab in Utah reporting to the QC Lab Manager and will work in collaboration with Quality Assurance to support Supplier Quality programs. The QC Technical Writer will be responsible for the determination of root cause and initiation of corrective/preventative actions designed to adequately address and correct the related deficiencies identified during the investigation process. Additionally, this role will be responsible for providing proactive corrections based on noted trends to minimize the potential for repeat events. This position requires working both in a team and as an individual contributor, with minimal supervision to manage assigned investigations from initiation to completion.

WHAT YOU'LL DO:

Write, review and approve technical documents such as method, specifications, validation protocols, validation reports, transfer protocols and reports, Standard Operating Procedures based on corporate policies, compendia requirements, ICH and FDA guidelines.
Develop, support and maintain Method, Specification and Laboratory SOP processes.
Initiate and review Change Controls for method/specification and SOP revisions; ensure timely handling and closure. Communicate with cross functional teams on changes in specification and method.
Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing, and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation has on the product, process, and consumer health and safety.
As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as mitigate risk to future operations.
Prepares and analyzes data, using root-cause analysis tools to accurately determine root causes and effectively communicate the issue, root cause, and corrective recommendations to management.
Properly assess manufacturing environments, independently advise management on appropriate corrective/preventative actions designed to mitigate operational deficiencies identified in the investigative process using industry accepted analytical tools.
Assess processes for change management and generate change controls with appropriate actions, considering impact to validated systems, current products, and patient health and safety.
Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
Works cross-functionally with other teams within AG and external business partners as needed to complete investigations.
Partner closely with Supplier Quality to assist with reviewing documentation provided by suppliers for accuracy and completeness; notify the QA Manager when suppliers do not provide the required documents or are out of compliance with Foreign Supplier Verification protocol.
Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems.
Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
Perform any other tasks/duties as assigned by Management.