The QC Technical Data Reviewer, reporting to the Director of Quality Control at the East Norriton, PA site, will ensure the quality of laboratory data and reports. He/she will perform accurate and timely technical review of QC data, ensuring compliance to cGMPs and to Standard Operating Procedures (SOPs), while meeting clients' deliverables.
The QC Data Reviewer will review a variety of data including, but not limited to, flow cytometry, qPCR and ddPCR data. He/she will utilize technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvements, and assist in resolving laboratory investigations as needed.
In addition to the Quality Control testing teams, the Senior QC Data Reviewer will also collaborate with QC Record Investigators and Quality Assurance specialists to ensure timely completion of deliverables.
Job Responsibilities:
Perform QC technical, scientific and compliance review of data and documentation generated by the Quality Control laboratories to enable Certificate of Analysis (CoA) generation.
Closely work with QC analysts, QC leadership and QA to perform expedited data review and communicate in-process results to Manufacturing.
Lead/coordinate assigned functional sub-teams; participate in function-specific teams and fulfil assigned project tasks and responsibilities under minimal supervision.
Participate in data integrity initiatives representing QC.
Identify and drive operational excellence and continuous improvement opportunities.
Complete all required job specific cGMP, Data Integrity, and EHS trainings and adhere/comply to appropriate standards defined for quality, ethics, health, safety, environment, and information security.
Understand the requirements, expectations and needs of internal and external customers and interact in courteous, professional, supportive, and collaborative manner.
Minimum Qualifications:
Bachelor of Science degree in Biology, Biochemistry, Molecular Biology or other relevant fields, A combination of relevant education and experience will be considered in lieu of degree.
Significant experience in a laboratory setting
Knowledge and experience with cGMP Quality Systems.
Preferred Qualifications:
Working understanding of flow cytometry, PCR and ELISA assays
Experience with Laboratory Information Management System (LIMS) and electronic laboratory notebook (ELN)
Other Ideal Personal Characteristics:
Demonstrated ability to take ownership, initiative, and self-accountability
Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting
Attention to detail and quick learning/application of concepts and information