Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
Perform basic microbiology testing such as but not limited to bioburden, water testing, swab testing, identification and other microbiological testing methods.
Prepare test solutions, sample, and or reagents as needed.
Prepare and standardize Test solutions, Standard solutions and Volumetric solutions.
Maintain mobile phase, solutions etc., for expiry and inventory.
Perform equipment and instrument calibrations/verification according to establish procedures.
Manage media and reagents supplies, input orders on WorkflowGen system.
Maintain good housekeeping, schedule and monitor housekeeping activities
Ensure that work order documentation is complete in every aspect and all results are entered into the electronic Laboratory Information System or the Client’s Certificate of Analysis before submission to the QA reviewer.
Prioritize, schedule and plan daily work in order to maintain efficient workflow to assure completion of scheduled tasks and to meet established due dates.
Report and Assist in the failure investigations as instructed.
Record findings in standardized format, keeping all records and analyst notebook in good order.
Record data in timely manner.
Inform the Department Manager and/or Group/Scientific Leader, as far in advance as possible, if the assigned work order cannot be satisfactorily completed within established scheduled time and quality of work expectations.
Perform additional assigned lab duties and periodically update Department Manager and/or Group/Scientific Leader on the status.
Attend training sessions and inform the Department Manager and/or Group/Scientific Leader if there is any doubt regarding the ability to fulfill testing requirements satisfactorily.
Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing.