-
ID
#45434334 -
Job type
Permanent -
Salary
TBD -
Source
Apex Systems -
Date
2022-09-03 -
Deadline
2022-11-02
Quality Assurance Specialist
Illinois, Chicago, 60601 Chicago USAPermanent
Vacancy expired!
- Oversee the electronic Documentation, Change Control and Training system.
- Implement the Quality Management System (QMS) for the organization.
- Manage and oversee equipment calibration activities.
- Establish Standard Operating Procedures (SOPs) and specifications for various quality and manufacturing processes.
- Collaborate with the purchasing / inventory specialist to ensure raw materials from external suppliers meet quality requirements.
- Establish Vendor score cards and perform supplier audits for critical vendors.
- Review Production Batch Records and manage disposition of material at each step of the manufacturing process.
- Collect, compile, and analyze relevant quality data and obtain information regarding quality performance.
- Manage non-conformance reports (NCRs) and trend non-conforming data regarding product and processes.
- Conduct quality control tests / inspections to verify quality of incoming material and finished goods.
- Review existing processes, specifications, and documents and identify improvement opportunities as seen fit.
- Minimum of Bachelor's degree in business management or administration, Biology or Bioengineering or related fields.
- Previous quality assurance role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
- Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.
- Excellent organizational and communication skills, with a mindset on driving quality-oriented activities.
- Strong analytical and problem-solving skills.
- Strong ability to collaborate with cross functional teams.
Vacancy expired!
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