~Performs cell based bioassay.
~Writes and revises SOPs for managerial review and approval.
~Performs broad range of troubleshooting techniques and leads such within area of expertise.
~Supports/Leads Laboratory investigations
~Trains less experienced analysts on basic and some more complex test methods.
Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent is required.
A minimum of 4 years experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
Experience in analytical test methods such as Bioassay and ELISA
Strong detail orientation with strong general laboratory and good organizational skills
Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints
Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
Demonstrates leadership, problem solving and analytical thinking skills.
QC Chemistry Specialists will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned.
Specialists will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.Occasional contact with other line management staff relating to investigation support, or specific project responsibilities may be expected.
Specialists primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.
Incumbents normally receive general instructions on routine work and general instructions on new assignments.
No direct supervision, but the Specialist will be expected to participate in the training of less experienced staff in normal operational tasks.
Associated topics: assistant, intern, internship, lab, laboratory, lab tech, lab technologist, qa, qc, sample collection