Quality Assurance Project Specialist
- LinkUs is a relational database that is currently being used to capture the knowledge generated during the small molecule Product Transfer Process.
- They will help to translate technical documents on drug substance (DS) and drug product (DP) manufacturing and enter the relevant information.
Source documents include, but are not limited to:
- Process Control Justification (PCJ), Process Development Reports (PDRs), Risk Assessment Memos, process Failure Modes and Effects Analysis (FMEAs), Exception Reports, Batch Records, Correction and Preventative Actions (CAPAs) and Development Modifications.
- Strong science and/or technical background.
- Technical understanding of manufacturing, especially pharmaceutical manufacturing.
- Basic understanding of Quality Risk Management.
- Computer literacy and an ability to become proficient with new computer software.
- Strong collaborator, sharing information freely.
- Good verbal and written communication skills.
- A strong understanding of 5 Why s to facilitate connecting why something happens to cause.
- Demonstrated record of problem solving, relentless curiosity.
- Focus on continual improvement.
- Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
- Learns fast, grasps the "essence" and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Prefer bachelor s degree.
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