QA Associate - IDAP, 3rd Shift
$75,000–$90,000 year
On-siteFishers, Indiana, United States
Job Summary
Maintain a Quality Assurance presence on the manufacturing floor, reviewing and approving documentation including batch records, logbooks, and work orders. Collaborate with Manufacturing/Operations to lead investigations for equipment and process deviations, utilizing root cause analysis and risk tools to resolve issues and enforce best practices. Exercise rapid decision-making for product segregation and corrective actions while prioritizing production timelines against quality assurance requirements. Utilize automated systems like Veeva and SCADA to ensure data integrity and analyze deviations using statistical methods. Support QA personnel with material release and cross-functional deviation processes, championing a culture of efficiency and compliance. Work primarily the third shift (11:00pm-7:30am) with occasional weekend support.
Required Qualifications
- Third shift availability (11:00pm-7:30am)
- Occasional weekend support
- Bachelor's Degree
- Degree in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
- Visual acuity of 20/20 or better, with or without corrective lenses
- Color vision
- Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment
- Experience as an Operator within a Pharmaceutical Manufacturing environment
- Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.
- Understanding of Good Documentation Practices (GDPs) and its criticality
- Excellent written and verbal communication skills
- General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA)
- Reporting and data analysis software skills (Word, Excel, Visio, JMP, Minitab, etc.)
- Ability to manage multiple projects in a fast-paced environment
- Authorized to work in the United States on a full-time basis
Desired Qualifications
- Hands-on experience with aseptic manufacturing
- Experience inspecting finished products
- Knowledge of Acceptable Quality Limits (AQLs)
- Experience with Continuous improvement
- Experience with Six Sigma
- Experience with Lean principles
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