This position is responsible for performing routine and complex analytical testing and analyses of biopharmaceutical finished products or raw materials. Follow Training SOP for training and training records.
Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
Work as a team with other Analysts and communicate effectively with peers and superiors.
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.
Ensure that equipment is maintained in good order, perform calibrations and qualifications as required.
Record findings in standardized format, keeping all records and analyst notebook in good order.
With limited supervision, prepare study protocols, study reports, forms and SOP’s.
Record data in timely manner.
Is comfortable leading and/or participating in technical conversations with SGS clients. Inform the Department Manager and/or Group Leader/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.
Ability to execute method verifications, validations, transfers based on signed protocols with little supervision.