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Responsible for the analysis of samples entering the laboratory
MaINTAINING OPERATIONS OF THE QuAlity Control (QC) LABORATORy
Ensures that consumables are in stock,
Maintain general flow of work through laboratory,
No out of stock consumables in laboratory,
Follow systems put in place
SAMPLING AND TESTING
Samples and tests all items that require analytical assessment including but not limited to raw materials, intermediate production and finished goods as part of Lot Release where applicable. Monitors quality of the Reverse Osmosis (RO) water in the laboratory. Production Lot Release completed on due dates. Report on findings from analytical testing
Performs various tests
API Assay and Identification
Assay and identification of sample impurities
Test physical requirements of raw materials and finished goods
Checking product packaging
Tests are completed on scheduled due dates .Maintain Goods Receiving log books. API (Active Pharmaceutical Ingredient)
Performs various monitoring, such as but not limited to:
Environmental Health and Safety (EHS) controls
Temperature monitoring and control
No deviations .Maintaining logbooks according to your assigned responsibilities .Report findings to superior or relevant department. GLP – Good Laboratory Practices
laboratory COMPLIANCE WITH REGULATORY AND CORPORATE REQUIREMENTS
Compliance with relevant GLP requirements .SOP’s for instruments compiled and updated. Ensure trained on latest SOP relevant to your responsibilities and general laboratory quality standards. Instruments calibrated per procedure .Maintains housekeeping standards in the laboratory.
No areas of Special Concern identified as a result of internal or external audit findings Only latest SOP’s as per QSI index. Instruments calibrated on schedule. No visible chemical spills, broken glassware, microbiological contamination, untidy bench, damage to instrumentation or support devises, etc.
TEST RESULT investigations
Investigation of Out Of Trend (OOT) and Out Of Specification (OOS) results in accordance with specified SOP’s and method specifications
Completed within specified time frame .Root cause established following investigation
Environment, Health & Safety
Understand and implement relevant EHS Guidelines and performance expectations. Ensure that colleagues understand their roles and responsibilities and maintain compliance to relevant EHS guidelines and legislative requirements in accordance with Standard Operating Procedures. Keep up to date with EHS programs in accordance with the training matrix. Conduct and or participate in EHS .Reviews related to facility operations.
No major EHS, ISO, J&J audit findings .Lab incident rates. Training records .Methods developed to not use hazardous or environmentally harmful reagents. Continuos Improvement programme
A Diploma or Degree Analytical Chemistry
At least 2 years experience in the Pharmaceutical or related industry as an Analytical Chemist