Senior Quality Assurance Specialist
hace 3 semanas
Job Summary
We are seeking a skilled Senior Quality Assurance Specialist to join our team at Biopharma Consulting Services. In this role, you will be responsible for reviewing and approving product manufacturing processes, as well as ensuring compliance with quality standards.
About the Role
This is a challenging opportunity for a seasoned professional with expertise in manufacturing process audits and batch record review. The ideal candidate will have knowledge of DAI processes, PASx/MES applications, MAXIMO, SAP, and LIMS systems. Additionally, experience working on non-standard shifts, including nights and weekends, is highly valued.
Key Responsibilities
- Review and approve product manufacturing processes
- Evaluate batch records to ensure compliance with quality standards
- Participate in environmental characterization reports and sanitary utility system releases
- Lead investigations and site audits to identify areas for improvement
- Develop and implement site quality program procedures
- Support automation activities and facilities programs
- Provide guidance on risk assessments and work orders
Requirements
To be successful in this role, you will need:
- A Doctorate degree or Master's degree and 3 years of directly related experience, or
- A Bachelor's degree and 5 years of directly related experience, or
- An Associate's degree and 10 years of directly related experience, or
- A High school diploma/GED and 12 years of directly related experience
Compensation and Benefits
The estimated annual salary for this position is $95,000-$110,000, commensurate with experience. Additionally, we offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
Location
This position is based in the United States, with the possibility of remote work arrangements.
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