Sr. Technical Writer
About The Position
Independently investigates process deviations and customer complaints, determines root causes, and initiates corrective and preventative actions to address Quality deficiencies. The role also identifies trends and proactively recommends corrections to reduce the risk of repeat incidents that could lead to product discards, field actions, or recalls. The position requires minimal supervision and ownership of assigned investigations from initiation through completion. It includes assessing product, process, and patient health and safety risks; analyzing manufacturing and laboratory data; communicating findings to senior management; maintaining enterprise quality management systems; and providing technical assistance to site personnel.
Responsibilities
- Ensure compliance with relevant Standard Operating Procedures while gathering, analyzing, and applying internal and external information to assess the impact of process deviations and complaints on products, processes, and patient health and safety.
- Gather information from internal and external sources to evaluate the impact of deviations on previously manufactured products and the risk to future operations.
- Prepare and analyze historical manufacturing and laboratory analytical data, use root-cause analysis tools to determine causes, and communicate findings to senior management.
- Assess manufacturing or analytical environments and advise senior management on corrective and preventative actions using industry-accepted analytical tools.
- Provide technical expertise to ensure investigation actions are complete, thorough, accurate, and timely.
- Update and maintain enterprise quality management systems in accordance with governing procedures and policies, and perform trend analysis.
- Independently conduct deviation and complaint investigations under procedure-driven guidelines and make decisions that affect patient health and safety.
- Provide technical assistance to area supervisors, managers, and technical writers in solving complex problems.
- Maintain deadlines and monitor the need for extensions related to Subsequent Actions and Investigations.
- Meet commitments agreed upon with department management, comply with closure targets, and provide justification when commitments are not met.
- Comply with company documents, programs, and activities related to Health, Safety, Environment, Energy, and the Quality Management System.
- Perform other tasks as directed or requested by management or site leadership.
Benefits
- 401(k) plan with company contributions
- Paid vacation, holiday, and personal days
- Employee assistance program
- Medical, prescription drug, dental, and vision coverage
- Life insurance
- Disability coverage
- Wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
