Deviation Investigator – Quality Control

Takeda • Brooklyn Park, MN

1d

About The Position

About the role: 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. How you will contribute: 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 ie. Veeva workflows. Participate in internal or supplier audits. Develop and provide training on department-specific procedures and systems ie. 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

Requirements

• BA/BS required. Life Science discipline would be ideal.
• 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.
• Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.

Nice To Haves

• Previous experience with the following would be ideal. This includes 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.

Responsibilities

• Perform deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis.
• Responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures.
• 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 ie. Veeva workflows.
• Participate in internal or supplier audits.
• Develop and provide training on department-specific procedures and systems ie. 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

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees