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Specialist Technical Writing
Advanced Bio-Logic Solutions Corp Holly Springs , NC 27540
Posted 4 days ago
Description:Note:Hybrid: up to 60% onsite.
- Ideal candidate would be someone that can work independently, has a minimum of 8-10 years of experience and strong working knowledge of GMP/regulatory requirements within the QC laboratory.
- Candidate must have experience writing the following technical documents within the QC laboratory: SOPs/ Equipment Operation and Maintenance Procedures/ Validation and Qualification protocols with little guidance.
- Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup
- Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)
- Manage document lifecycle updates to support QC Laboratory Readiness metric reporting
- Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications
- Previous experience with the Pharmaceutical Industry, with a strong focus in GMP Quality Control
- Min 8 years' experience performing analytical testing.
- Master degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences or Engineering related discipline.
- Strong theoretical understanding, research in, and hands-on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non-GMP environments
- Experience with a broad array of chromatographic and spectroscopic techniques.
- Demonstrate independence and ability to produce quality results under minimal direction.
- Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
- High energy individual who can multi-task and handle a fast-pace, dynamic work environment
- Operate specialized laboratory equipment and instrumentation
- Complete training on assigned tasks
- Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
- Ideal candidate would be someone that can work independently, has a minimum of 8-10 years of experience and strong working knowledge of GMP/regulatory requirements within the QC laboratory. Candidate must have experience writing the following technical documents within the QC laboratory: SOPs/ Equipment Operation and Maintenance Procedures/ Validation and Qualification protocols with little guidance.
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