Category: Scientific & Clinical
Title: QC Analyst
Location: Rockville, MD
Summary of Position
This position is responsible for sampling and testing of incoming raw materials to support manufacturing of clinical and commercial products, and for preparation for shipment to contract testing sites of raw material samples, lot release samples and stability samples.
Responsibilities and Job Duties:
- Responsible for the inspection, sampling and testing of incoming raw materials (RM). Performs inspection, sampling and testing according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents and are completed per schedule and within established turn-around time.
- Collaborates with Materials Management to prepare shipments of raw material samples, lot release samples and stability samples for testing performed by contract laboratories.
- Follows established procedures and perform tasks in accordance with cGMP requirements.
- Assists in the development and revision of raw material specifications and testing plans, as needed for manufacturing of products and/or affected by compendia changes and/or changes arising from quality events.
- Assists in compendial review (USP, Ph. Eur., JP) for new and/or revised compendial requirements that apply to RM, and revises specifications accordingly.
- Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data per cGMP. 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 compliance and inspection readiness at all times and ensures that sampling room inventory is stocked with required cleaning solutions, sample containers, labels, etc. and coordinates with appropriate departments when there are issues/concerns.
- Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs).
- Prepares general lab solutions and buffers as needed and monitor expirations of these solutions and buffers.
- Other duties as assigned.
Education, Experience, & Credentials
- Bachelor’s Degree in a scientific discipline preferred
- 1+ year of GMP experience in a QC sample management
- Candidates must have experience working in clean rooms