KEY DUTIES AND RESPONSIBILITIES

• Assists in the completion and writing of Non-conformance Reports, Deviations, Investigations and other Operations documentation.
• Uses Root Cause Analysis and determines appropriate corrective actions to close gaps to gain efficiency in process.
• Facilitates retraining of staff as needed.
• Keeps reporting updated for trending and value add to the business.
• Assists in managing corrections in production records and batch records.
• Manage deviation files including ensuring timely completion of investigation activities and report closures.
• Partners with Quality to ensure clear documentation to quality impact assessments.
• Monitor open corrective/preventive actions and subsequent effectiveness checks.
• Ensure that activities are completed within assigned due dates for process change requests and CAPAs.
• Assists with projects as necessary.
• Perform other duties as assigned by StimLabs management.

EDUCATION/CERTIFICATION

• Bachelors degree preferred with industry experience or appropriate combination of educational and experience.
• Experience in combination at all levels, meticulous and self-motivated.
• Requires basic Microsoft Windows experience (MS Word, Excel, PowerPoint, Outlook, etc.)

REQUIRED KNOWLEDGE

• Experience working in an AATB and/or FDA regulated facility
• Able to manage multiple priorities; communicate effectively, training staff on shortcomings; and be able to present as required .
• Strong interpersonal and communication skills. An ability to communicate and present clearly and professionally with all levels of employees, leadership, consultants, and regulatory entities.
• Ability to apply critical thinking methods: define problems, collect and interpret relevant data, establish facts, draw valid conclusions, and implement countermeasures.
• Proven track record of meeting production, quality, and service deadlines
• Advanced computer skills including Microsoft Office products