Deviation Management Specialist
4 weeks ago
Insight Global is seeking a highly skilled Deviation Management Specialist to join our team. As a key member of our specialty products & services and incoming materials team, you will be responsible for ensuring that deviations are thoroughly investigated, risks are managed, and corrective actions are taken to maintain equipment quality & compliance in the pharmaceutical industry.
Key Responsibilities:- Author and review incident and investigation reports for deviations
- Coordinate and complete Corrective Actions and Preventive Actions (CAPAs)
- Author and review Incident Trend Reports
- Support deviation reduction efforts
- Support, execute, and/or lead continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process
- Examine complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause
- Author, update, and/or review and approve engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment
- Provide on-the-floor support for project implementation and studies, as required
- Lead or participate in Quality Risk Assessments
- Support team safety, environmental, and compliance objectives
- Manage project timelines to ensure key compliance and customer due dates are met; escalate any potential delays and develop remediation plans when possible
- Collaborate effectively with Operations, Quality, Planning, project teams, and external vendors
- B.S. or B.A. in Engineering, Sciences, or related discipline
- Minimum two (2) years post-bachelors degree experience in a regulated environment
- Experience in deviation management and/or change control and/or bio-pharm equipment
- Technical Writing
- Highly developed communication, leadership and teamwork skills
- Deviation Management
- Data Analytics experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Insight Global is an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.
If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
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