Job Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The QA Senior Specialist will serve as a member of the Sterility Assurance team providing knowledge for risk mitigation and contamination control. The candidate will gain a robust understanding of the aseptic processes and controls to ensure compliance and provide Quality support to site projects. The ability to work efficiently in a fast-paced environment, be hands-on, prioritize, analyze, and review potential risks and gaps is a must. Assessment of process controls, documentation, gowning, equipment, materials, and facility will be required. Off-shift or weekend coverage may be required, based on production schedule, or project-specific assignments to support business needs.
Position Responsibilities:
- Member of the Quality Sterility Assurance team, providing support to ensure compliance risk mitigation, contamination control, and sterility assurance of the facility.
- Gain robust understanding of the full manufacturing process, process requirements, and inputs.
- Manage and evaluate environmental monitoring trends and data for continuous improvement.
- Prioritize and analyze potential issues that relate to Sterility Assurance.
- Drive process improvements projects, company effectiveness, problem prevention.
- Review deviations, corrective and preventative actions, and SOPs.
- Participate in Quality Risk Assessments and initiatives.
- Train and mentor laboratory and operations staff on best practices as needed.
- Perform facility walkthroughs and audit aseptic technique and behaviors of laboratory and operations staff.
Education Minimum Requirements:
- Bachelor of Science degree in a science-related field.
Required Experience and Skills:
- Minimum of five (5) years of experience in a GMP related environment.
- Working knowledge of GMP and regulatory requirements.
- Aseptic technique and best practices.
- Knowledge of contamination control, risk mitigation, and sterility assurance.
- Technical writing experiences such as SOPs, protocols, deviations, CAPAs, gap assessments.
- Working both independently and within multi-functional teams.
- Excellent communication skills.
- Support of Quality projects and process improvement initiatives.
Preferred Experience and Skills:
- Sterile manufacturing experience.
- Aseptic Gowning knowledge and technique.
- Previous shop floor quality, quality control, or quality assurance experience.
- Dependable, flexible, high attention to detail.
- Audit and inspection support.
- Trending reports and analysis.
- Gap assessments and risk management.
- Project management.
Employee Status: Regular
Relocation:Domestic
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Hybrid
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:10/23/2024
Requisition ID:R317592
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