What unique gene will you bring to Celgene?
On the Quality Control team, we deliver our mission by testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site.
The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories.
Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-
functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME).
This position is primarily located at the Celgene site in Boudry. The Scientist may also be assigned responsibilities for activities or systems located at the Celgene site in Couvet.
As the Quality Control Scientist, Technical Support , you will be :
Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories.
Owns the change control, leads or supports risk assessments,
Performs feasibility experimental work as needed
Configures user-profiles and methods on the instrument.
Collaborates with Validation and Sourcing to define requirements and contracts for the periodic maintenance and requalification of the equipment.
Owns deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result.
Writes investigational testing plans to identify laboratory root cause.
Defines corrective and preventive actions (CAPA).
Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology.
Supports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning.
Leads or supports risk assessments, owns change controls.
Reviews method transfer plans. Performs or supports feasibility experimental work as needed. Supports method transfer, method verification and method validation activities.
Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Evaluates the impact of compendial changes on applicable QC procedures and opens change controls as required.
Actively participates in inspections by health authorities and in corresponding preparation.
Administers user-profiles and access to the systems,
Defines requirements and performs audit trail reviews, assures adherence to data integrity principles,
Authors instrument / system operating procedures and trains QC analysts on use of the system.
Performs master data management activities in computerized systems (LIMS, Oracle, Empower).
Knowledge and skills required