Position Summary:
Responsible for bulking and filtration container set ups, performs filtrations of bulk materials, and manufactures buffers/stock solutions per manufacturing procedures with limited supervision. Participates in process improvement projects.
Key Responsibilities:
• Assist in manufacture of controls and calibrators and complete batch records following cGMPs.
• Perform in-process assays using equipment such as spectrophotometers, pH meters and clinical analyzers.
• Prep Small parts for washer and autoclave.
• Build and change valve diaphragms.
• Weighing, transfer, mixing of chemicals required.
• Perform product filtrations.
• Clean and Steam in place steam steel tanks and transfer lines.
• Prepare glassware and steel tanks for sterilization in autoclave and operate autoclave.
• Maintain lab equipment including pumps, pH meters, and flow meters.
• Keep department lead or manager updated on all issues.
• Monitor stocks of common lab supplies.
• Performs other job duties as required.
Minimum Requirements/Qualifications:
• High school diploma or equivalent. AA degree preferred with some cGMP lab experience.
• Basic lab skills and knowledge of safety precautions.
• Familiarity with Quality System Regulations.
• Experienced working with potentially hazardous chemicals and human source materials.
• Must be able to lift 25 lbs routinely.
• May be required to lift up to 50 lbs occasionally.
Non-Negotiable Hiring Criteria:
• Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
• Ability to read and write English and understand instructions written or orally in English.
• Ability to add, subtract, multiply and divide in all units of measure, whole numbers, fractions and
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