Job Description

pay 60-80/h depending on experience

Job Description:
Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, company processes and procedures to support GMP manufacturing.  
Job Duties:
? Author technical documents including SOPs, Test Methods, Method Verification/Validation Protocols & Reports, Material Specifications.
? Perform compendial (USP/EP) testing of raw materials (starting materials, excipients, primary packaging, manufacturing water) to support manufacturing operations.
? Perform method verification/method validation of raw material test methods.
? Perform QC sampling of raw materials in a cleanroom environment.
? Lead the qualification of QC analytical instruments by authoring and executing IQOQ protocols/reports. 
? Lead investigations for OOS results, lab discrepancies, and invalid assays.
? Support QC sample management with the receipt of manufacturing samples.
? Manage receipt and inventory of reagents and supplies for the laboratory.
? Participate in internal and external GMP audits, as needed.
? Undertake any other duties as required. 
Core Competencies, Knowledge, and Skill Requirements
Minimum of 5 years with a Bachelor’s or above in Chemistry or related scientific discipline.  
? Working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
? Working knowledge and experience with raw material sampling in a cleanroom environment. 
? Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, FTIR, Raman spectroscopy, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods.
? Strong working knowledge with USP/EP and cGMP/EU GMP.
? Technical writing experience.
? Familiar with instrument and equipment validation.
? Credible and confident communicator (written and verbal) at all levels.
? Strong analytical and problem-solving ability.
? Hands-on approach, with a ‘can do’ attitude.
? Ability to prioritize, demonstrating good time management skills.
? Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
? Self-motivated, with the ability to work proactively using own initiative.
? Committed to learning and development.

Job Tags

Contract work, For contractors, Work experience placement,

Similar Jobs