Deviation Investigator – Quality Control

Role Summary

As a Deviation Investigator - Quality Control, you will perform deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis. You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures. Location: Brooklyn Park, MN.

Responsibilities

• Operate Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles).
• Monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics.
• Lead Global EQMS projects related to EQMS topics (e.g., Community of Practice, workstream participation).
• Review and write deviations, investigations, change controls and CAPAs associated with cGMP compliance.
• Review and approve deviations for compliance to IQS standards.
• Identify, investigate, and resolve complex technical issues using problem-solving skills.
• Analyze and interpret projects, studies, or investigations to determine next steps.
• Write and revise documents independently.
• Perform QA review/approval of controlled documents i.e. Veeva workflows.
• Participate in internal or supplier audits.
• Develop and provide training on department-specific procedures and systems e.g. Deviations, IQS.
• Participate in required training and keep training files current.
• Identify, propose, and implement Quality Process and system improvements.
• Help implement global QA approaches based on sound principles, international industry/regulatory standards, and scientific basis.
• Assist in troubleshooting issues related to quality concerns, implementing solutions and corrective actions.

Qualifications

• 5+ years' experience in regulated (food, medical device, or pharma/biotech) industry preferred.
• Direct experience with Quality Assurance within the Life Science industry strongly desired.
• Understand and apply comprehensive knowledge of quality and GMP principles. Maintain current understanding of global GMP regulations.
• Previous experience with auditing, basic statistics, and peer review/approval of documentation. Experience with Quality Training, Quality Improvement Tools, and Supplier Quality is desired. Technical Writing and Review, and Writing/reviewing/approving investigations, are also valuable.
• Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.

Education

• BA/BS required. Life Science discipline would be ideal.

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand or sit: must be able to remain in a stationary or standing position for extended periods of time.
• In general, the position requires mostly sedentary work with occasionally walking throughout the facility.
• Wrist and hand motion (e.g., typing, writing) while operating office equipment such as computer, phone, calculator, etc.
• Willingness to travel to various meetings or client sites, including overnight trips.
• Requires approximately 0-5% travel.