Senior Quality Control Data Review Specialist
This position will be responsible for managing the review and approval of all GMP data generated by QC and contract testing organizations, including paper and electronic data.
Under the general guidance of the QC Data Review Lead, s/he will work independently to ensure data integrity and all GMP/GDP and regulatory requirements are met.
The responsibilities include but not limited to:
Review laboratory records and test results, both paper-based and in electronic format (i.
e.
LIMS), including audit trails, for completeness and accuracy Ensure the assay records and related information are compliant to test method, procedures, specifications, cGMP, and internal SOP requirements and scientifically sound Communicates with analysts and laboratory managers to proactively address quality impacting issues Provide support as required to address data related issues internally or in collaboration with other departments as a member of a cross-functional team.
Contribute to the data integrity improvement project Author and revise SOP, investigation, CAPA Support audits and regulatory inspections Performs other duties as assigned Train junior team members Review internal GMP assay records and results and electronic data, as well as contract testing lab's reports, records, and data to support lot release and other QC studies Review audit trails of instruments Author and revise SOP, deviation, investigation, and CAPAs Collaborate with analyst and management to address issues identified during data review Work with internal and external stake holders to improve data integrity by strengthening data review process.
Train new team members Provide support to audit and inspection Minimum Requirements BS, MS or higher degree on biological, chemical sciences, or related discipline 2
years for BS, 1
years for MS, 1+years for PhD, of related experience in the Pharmaceutical/Biotech industry working in a GMP/regulated environment Previous GLP/GMP data review experience Thorough knowledge of molecular biology, virology, cell biology, and/or biochemistry assays, such as viral titer, potency, impurity and safety testing.
General knowledge of other analytical assays is a plus Experience in analytical instrument audit trail review preferred Desired Skills Experience in data review in LIMS preferred Experience in process improvement Experience of training Recommended Skills Auditing Biochemistry Biology Biotechnology Business Process Improvement Cell Biology Estimated Salary: $20 to $28 per hour based on qualifications.
Under the general guidance of the QC Data Review Lead, s/he will work independently to ensure data integrity and all GMP/GDP and regulatory requirements are met.
The responsibilities include but not limited to:
Review laboratory records and test results, both paper-based and in electronic format (i.
e.
LIMS), including audit trails, for completeness and accuracy Ensure the assay records and related information are compliant to test method, procedures, specifications, cGMP, and internal SOP requirements and scientifically sound Communicates with analysts and laboratory managers to proactively address quality impacting issues Provide support as required to address data related issues internally or in collaboration with other departments as a member of a cross-functional team.
Contribute to the data integrity improvement project Author and revise SOP, investigation, CAPA Support audits and regulatory inspections Performs other duties as assigned Train junior team members Review internal GMP assay records and results and electronic data, as well as contract testing lab's reports, records, and data to support lot release and other QC studies Review audit trails of instruments Author and revise SOP, deviation, investigation, and CAPAs Collaborate with analyst and management to address issues identified during data review Work with internal and external stake holders to improve data integrity by strengthening data review process.
Train new team members Provide support to audit and inspection Minimum Requirements BS, MS or higher degree on biological, chemical sciences, or related discipline 2
years for BS, 1
years for MS, 1+years for PhD, of related experience in the Pharmaceutical/Biotech industry working in a GMP/regulated environment Previous GLP/GMP data review experience Thorough knowledge of molecular biology, virology, cell biology, and/or biochemistry assays, such as viral titer, potency, impurity and safety testing.
General knowledge of other analytical assays is a plus Experience in analytical instrument audit trail review preferred Desired Skills Experience in data review in LIMS preferred Experience in process improvement Experience of training Recommended Skills Auditing Biochemistry Biology Biotechnology Business Process Improvement Cell Biology Estimated Salary: $20 to $28 per hour based on qualifications.
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