Quality Control Analyst

(M-F/8hr shift)

Location: Holly Springs, NC (Onsite only)

Job Description:

Primary responsibilities for this position include performing tasks associated with USP/EP Compendia for GMP release of raw materials and drug product. The analyst will be responsible for ensuring that Seqirus samples are tested according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.
nalyst will be required to write change controls, raw material specifications, and perform minor project management work to maintain specifications.

Major Accountabilities:
•Performs USP/EP testing for QC samples
•Performs GMP testing and associated tasks without errors per applicable SOPs and protocols
•Writes change controls, raw material specifications, and project manages changes related to raw material enrollment
•Coordinates material shipments to third-party vendors
•Serve as a liaison within multifunctional departments for testing requests.
•Assist in laboratory and instrumentation onboarding
•Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
•Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
•Participates and performs in cross-training to support staff availability within QC department
•Develop expertise in assigned assays/techniques
•May be required to perform shift work to support operational needs

Minimum Required Qualifications:
•Bachelor's degree in a Scientific discipline
•Some experience with GMPs, safety regulations, and data integrity
•Some experience with analytical methods and related instrumentation

Preferred / Nice to Have Qualifications:
•2 years of industry experience is a plus
•Knowledge of DLS (Dynamic Light Scattering) testing
•GLIMS LabWare and Empower experience
•Knowledge of Flow Cytometer
•Quantitative and Qualitative PCR experience
•Trackwise and SAP experience
•Adherent Cell Culture experience
•Molecular and cell-based assay experience
•Technical writing skills
Pay rate that is commensurate with their level of experience.