Summary of Position:
This position is responsible for the sampling and testing of incoming raw materials to support the manufacturing of MacroGenics clinical and commercial products. Also responsible for the preparation of raw materials, lot release samples and stability samples for shipment to contract testing sites and training lower level colleagues. This position may also be responsible for the sampling and testing of other samples, i.e. drug substance and stability samples.
Responsibilities and Job Duties:
- Performs inspection, sampling and testing of incoming raw materials according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents, per schedule and within established turn-around times.
- Collaborates with Materials Management to receive and prepare shipments of raw material samples, lot release samples and stability samples for testing performed by contract laboratories.
- Follows established procedures and performs tasks in accordance with cGMP requirements.
- Prepares composite samples and aliquots using aseptic technique in ISO 5 and ISO 8 areas and in biological safety cabinets.
- Performs and trains others on routine analytical testing including more complex methods such as cell culture and growth promotion as well as basic methods such as concentration by UV absorbance, pH, conductivity, appearance and osmolality, draeger tube gas testing, Raman IR, and environmental monitoring, in accordance with all protocols and procedures.
- Assists in the development and revision of raw material specifications and testing plans, as needed for manufacturing of MacroGenics products and/or affected by changes arising from quality events.
- Assists in compendial review (USP, Ph. Eur., JP) for new and/or revised compendial requirements that apply to MacroGenics raw materials, and revises MacroGenics specifications accordingly.
- Performs physical inspections of stored materials and maintains accurate tracing / tracking of Quality Control sample and retain inventory.
- Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data generated by others ensuring data integrity and adherence to SOPs. Ensures data storage and archiving are performed per established procedures.
- Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state and raises any concerns about equipment to supervisor for resolution.
- Maintains the sampling room at constant state of cleanliness, compliance and inspection readiness and ensures that sampling room and sample packaging inventory is stocked with required cleaning solutions, sample containers, labels, etc. Orders materials via SAP.
- Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs) in electronic document management system (MasterControl), and coordinates with appropriate departments when there are issues/concerns.
- Prepares general lab solutions and buffers as needed and monitors expiration of these solutions and buffers.
- Performs other duties as assigned.