Compliance Specialist III - OQSIE
Swiftwater, PA
About the Job
The purpose of this position is to manage the quality and compliance aspects and risks associated with manufacturing activities, test method qualification, validation and testing of clinical trial material (CTM) in accordance with cGMP standards, and regulatory and internal requirements to ensure the final release of compliant CTM.
This purpose is achieved through project team membership, providing adequate Quality oversight and expertise for the review of the completed batch production records, process specific records, analytical test records, environmental monitoring data, deviation/change control related forms, quality audits (internal and external), and investigations.
Skills: KEY ACCOUNTABILITIES
(List the 6-8 most important responsibilities of the job. For each key responsibility indicate the action to be taken, the end result to be achieved, and how it will be achieved. Include the % of time spent on each responsibility. Total of percent should equal 100 %.)
Project Team Representation& Quality Oversight
Responsible for representing R&D QA on project team and/or sub-teams and/or working groups (CTM, CMO, CMC) in order to provide direction on quality issues and regulatory compliance with respect to all aspects of manufacturing and testing.
Ensure appropriate disposition of CTM manufactured products to the clinical trial site in accordance with the Clinical Trial Protocol and provide disposition in the event the CTM is subjected to one or several cold chain breaks
This position requires the investigation, evaluation, recommendation, tracking and trending of all product issues according to regulatory and internal procedures
Documentation Review and Approval
Responsible for the review, assessment, and where applicable, the approval of original and revised procedures (e.g. relevant SOPs, directives, guidelines, policies), detailing all aspects of testing of clinical trial materials, equipment operations, and quality procedures for quality content and compliance to cGMPs.
Coordination of Failure Investigations and Assessment of CAPAs/Changes
Responsible for coordinating the investigation and timely closure of deviations that occur during manufacturing or testing of clinical trial material. This includes recommendations for disposition based on assessment (root cause analysis) and follow-up for closure of corrective and preventative actions (CAPAs) initiated by the respective areas, as well as the tracking, resolution and timely closure of associated change control requests that impact product and processes. Quality metrics to be established, captured, assessed and reported in QA's quality metrics program.
Review of CTM Manufacturing & Analytical Testing Records
Responsible for the timely reviews of manufacturing records for completeness and accuracy. This includes the review of batch specific documentation to verify acceptability, the review of process specific records for conformance, the review of analytical records (and associated Certificates of Analysis) to verify all required testing has been performed and all testing meets requirements prior to release, the review of environmental monitoring data as required prior to batch release, and the review of deviation/change control forms to verify acceptability of issues and their resolutions
Release of Clinical Batches
Responsible for prioritized release of all clinical batches (and associated steps) produced either in-house or made on contract according to regulatory and internal requirements as well as in accordance to company strategic objectives. The release activity includes the verification of all associated reviews to ensure consistency of the overall batch record and that all previous manufacturing steps including raw materials have been released prior to release of the batch and the verification that any associated deviations and/or other batch discrepancies have been resolved prior to release and approval of contractors for pharmaceutical manufacturing.
Responsible for ensuring that site archiving rules are followed for batch documentation
Keywords:
Education: Education/experience
(Minimum) Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry
(Preferred) Master of Science Degree, specializing in Biology, Microbiology, Biochemistry
Minimum 5 years related experience in Pharmaceutical Manufacturing and Quality Operations
Excellent report writing and communication skills
Excellent knowledge of the GMPs, GxP for US, Canada and Europe
This purpose is achieved through project team membership, providing adequate Quality oversight and expertise for the review of the completed batch production records, process specific records, analytical test records, environmental monitoring data, deviation/change control related forms, quality audits (internal and external), and investigations.
Skills: KEY ACCOUNTABILITIES
(List the 6-8 most important responsibilities of the job. For each key responsibility indicate the action to be taken, the end result to be achieved, and how it will be achieved. Include the % of time spent on each responsibility. Total of percent should equal 100 %.)
Project Team Representation& Quality Oversight
Responsible for representing R&D QA on project team and/or sub-teams and/or working groups (CTM, CMO, CMC) in order to provide direction on quality issues and regulatory compliance with respect to all aspects of manufacturing and testing.
Ensure appropriate disposition of CTM manufactured products to the clinical trial site in accordance with the Clinical Trial Protocol and provide disposition in the event the CTM is subjected to one or several cold chain breaks
This position requires the investigation, evaluation, recommendation, tracking and trending of all product issues according to regulatory and internal procedures
Documentation Review and Approval
Responsible for the review, assessment, and where applicable, the approval of original and revised procedures (e.g. relevant SOPs, directives, guidelines, policies), detailing all aspects of testing of clinical trial materials, equipment operations, and quality procedures for quality content and compliance to cGMPs.
Coordination of Failure Investigations and Assessment of CAPAs/Changes
Responsible for coordinating the investigation and timely closure of deviations that occur during manufacturing or testing of clinical trial material. This includes recommendations for disposition based on assessment (root cause analysis) and follow-up for closure of corrective and preventative actions (CAPAs) initiated by the respective areas, as well as the tracking, resolution and timely closure of associated change control requests that impact product and processes. Quality metrics to be established, captured, assessed and reported in QA's quality metrics program.
Review of CTM Manufacturing & Analytical Testing Records
Responsible for the timely reviews of manufacturing records for completeness and accuracy. This includes the review of batch specific documentation to verify acceptability, the review of process specific records for conformance, the review of analytical records (and associated Certificates of Analysis) to verify all required testing has been performed and all testing meets requirements prior to release, the review of environmental monitoring data as required prior to batch release, and the review of deviation/change control forms to verify acceptability of issues and their resolutions
Release of Clinical Batches
Responsible for prioritized release of all clinical batches (and associated steps) produced either in-house or made on contract according to regulatory and internal requirements as well as in accordance to company strategic objectives. The release activity includes the verification of all associated reviews to ensure consistency of the overall batch record and that all previous manufacturing steps including raw materials have been released prior to release of the batch and the verification that any associated deviations and/or other batch discrepancies have been resolved prior to release and approval of contractors for pharmaceutical manufacturing.
Responsible for ensuring that site archiving rules are followed for batch documentation
Keywords:
Education: Education/experience
(Minimum) Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry
(Preferred) Master of Science Degree, specializing in Biology, Microbiology, Biochemistry
Minimum 5 years related experience in Pharmaceutical Manufacturing and Quality Operations
Excellent report writing and communication skills
Excellent knowledge of the GMPs, GxP for US, Canada and Europe
Source : OQSIE
