KEY DUTIES AND RESPONSIBILITIES

The Sr. Production Investigator reports to the Operations Manager or Director and oversees the day-to-day activities of document creation, investigation, writing and organization in the Operations department at StimLabs.

• 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
• Facilitates retraining of staff as needed.
• Keeps lists updated for control of records / binders.
• Assists in managing corrections in production records and batch records.
• Files paperwork in batch records ensuring compliance.
• Manage deviation files including ensuring timely completion of investigation activities and report closures
• Monitor open corrective/preventive actions and subsequent effectiveness checks. Ensure that activities are completed within assigned due dates
• 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