This position will be responsible for performing in-process, release and stability assays supporting GMP manufacturing of commercial products, validation testing and R&D testing as needed.
• Conduct routine tasks to support the review and release of final product following established procedures.
• Perform GMP support functions and assays, such as reagent preparation, chemistry assays, protein assays, HPLC, SDS-Page, Western Blots and ELISA’s.
• Complete all assay method training and assigned testing on schedule and routinely maintain high throughput of analytical assays with accurate, precise, and reproducible results.
• Initiate Sentry events and assist investigations to identify root cause of non-conformance and implementation of corrective and preventative action plans.
• Initiate and perform OOS/OOT investigations
• May interact with other departments (QA, Fac Ops, Manufacturing, Supply Chain) to ensure testing is performed in a timely manner.
• Legibly document testing results in order to meet regulatory requirements to ensure completeness and accuracy per cGMPs.
• Perform GMP review of completed QC test report forms. Ensure that data entry in LIMS database is current for data in scope.
• Maintain GMP systems supporting routine testing and demonstrate continued adherence to compliance standards defined in cGMP’s
• Other duties when assigned.
Key Performance Indicators:
• Consistent levels of performance/productivity, and demonstration of knowledge of relevant product lines and quality systems.
• Sound decision to ensure no delays in schedules and operations
• Strong written and verbal communication skills
• All required trainings are up-to-date
Education (minimum/desirable): BS in Chemistry, Biology or related field, or equivalent combination of education and experience
Analyst: 0 - 3 years with BS in sciences or related field
Senior Analyst: 3 - 10 years with BS in sciences or related field or an MS in sciences or related field with 0 to 3 years experience
• Highly motivated towards achievement and task oriented.
• Strong analytical and critical thinking skills.
• Knowledgeable in protein chemistry techniques such as pH, Lowry Protein Determination, SDS-PAGE, Western Blot, ELISA, HPLC, and reagent preparation.
• Excellent technical and pipetting skills as well as strong oral and written communication skills.
• Proficiency in MS Word and MS Excel.
• Ability to effectively organize and manage personal work schedule independently a must.