Job Description
When it comes to staffing solutions, our strong ties to various talent pools allow us to fulfill the contract and permanent positions for any size company, ranging from Global 2000 Companies to implementation partners.
- Manufacturing process development and validation, including writing Standard Operating Procedures (SOPs), Batch Production Records (BPR), validation protocols and reports, and release specifications. Ensuring that quality objectives are met
- Oversight of manufacturing, QC, and materials release processes. Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods. Troubleshoot and remediate materials that do not meet specifications
- Interface between R&D, program management, and quality to meet regulatory and demand requirements.
- Reviews deviations, change controls, and quality control data for in-process and finished products.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
Skills and experience
- BA/BS in science (Biochemistry, biology, chemistry, etc)
- Previous working experience in a regulated environment (e.g. medical device or pharmaceutical) is required.
- Experience with manufacturing/formulating of bulk materials; manufacturing/QC experience working in a GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices) environment is a plus
- Supervising Manufacturing Technicians
- Analysis of data generated by functional assays.
- Experience with performing internal audits is a plus.
- Experience with immunoassays (ELISA, automated immunoassay) or sequencing based assays is a plus.
- Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, a are essential.
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