Supervisor, Quality Control
Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope technology is the world's first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope is an ideal platform for developing the next generation of tissue-based companion diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.
Duties and Responsibilities
Plan, schedule and supervise routine QC activities of the QC staff. Manage the priorities in accordance to weekly MFG/QC planning meeting.
Review incoming QC records as well as analytical and functional testing reports during product release.
Write, revise, and review QC SOPs, incoming Raw Material QC Spec and other Good Manufacturing Practices (GMP) documentation.
Perform analytical and functional testing of routine and non-routine samples and document according to GMP/or ISO 13485 standard. Collect, analyze and interpret QC data.
Establish a system for managing test samples, reagents and reference standards. Ensure QC laboratory compliance to established specifications and procedures.
Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
Identify discrepancies, participate in quality investigations and CAPA initiatives as needed. Assure the implementation of appropriate and timely corrective actions.
Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality System.
Ensure QC equipment is maintained in a qualified state.
Follow all established laboratory, regulatory, safety, and environmental procedures.
Perform other duties as assigned. A BS/MS in molecular biology, biochemistry, cell biology or related field with at least 5 years of laboratory experience of which 2 years in tech lead or supervisory role.
Experience in molecular biology techniques, microscopy and imaging, and cell culture
Experience in histology and tissue/cell-based assays such as immunohistochemistry and in situ hybridization is preferred
Experience in ISO 13485 and GMP regulated environment a plus
Experience in setting up and maintaining QC laboratory practices compliance to GMP requirements
Operate as a team leader and develop staff to maximize contributions to team and company
Previous experience with ERP System preferred
Ability to multi-task and prioritize work assignments with little supervision.
Excellent organization and analytical skills.
Excellent verbal and written communication skillsEstimated Salary: $20 to $28 per hour based on qualifications.
Duties and Responsibilities
Plan, schedule and supervise routine QC activities of the QC staff. Manage the priorities in accordance to weekly MFG/QC planning meeting.
Review incoming QC records as well as analytical and functional testing reports during product release.
Write, revise, and review QC SOPs, incoming Raw Material QC Spec and other Good Manufacturing Practices (GMP) documentation.
Perform analytical and functional testing of routine and non-routine samples and document according to GMP/or ISO 13485 standard. Collect, analyze and interpret QC data.
Establish a system for managing test samples, reagents and reference standards. Ensure QC laboratory compliance to established specifications and procedures.
Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
Identify discrepancies, participate in quality investigations and CAPA initiatives as needed. Assure the implementation of appropriate and timely corrective actions.
Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality System.
Ensure QC equipment is maintained in a qualified state.
Follow all established laboratory, regulatory, safety, and environmental procedures.
Perform other duties as assigned. A BS/MS in molecular biology, biochemistry, cell biology or related field with at least 5 years of laboratory experience of which 2 years in tech lead or supervisory role.
Experience in molecular biology techniques, microscopy and imaging, and cell culture
Experience in histology and tissue/cell-based assays such as immunohistochemistry and in situ hybridization is preferred
Experience in ISO 13485 and GMP regulated environment a plus
Experience in setting up and maintaining QC laboratory practices compliance to GMP requirements
Operate as a team leader and develop staff to maximize contributions to team and company
Previous experience with ERP System preferred
Ability to multi-task and prioritize work assignments with little supervision.
Excellent organization and analytical skills.
Excellent verbal and written communication skillsEstimated Salary: $20 to $28 per hour based on qualifications.
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