Sr Specialist R&D QA at CSL Limited in Holly Springs, NC
Major Accountabilities:
Provide Quality oversight of R&D activities Ensures bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP. Supports the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development. Reviews and approves executed batch records and development/validation/qualification protocols Ensures data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness. Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP) Authors phase appropriate FLQA procedures for oversight of clinical manufacturing activities Provides QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required Provides QA oversight to level 0 changes and minor deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations Supports the implementation of the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations, and identified areas for continuous improvement Establishes relationships with R&D QA and other global Quality functions:
Advises R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets Helps maintain the Quality System in R&D Identifies and escalates risks to compliance to senior management Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities Supports internal audits and helps prepare for regulatory inspections Supports inspection finding responses related to applicable area of oversight Supports the provision of accurate and timely reports on metrics, findings, risks and trends Minimum Requirements:
Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred. 3
years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry. Previous work in a QC, Research, Development, Manufacturing or Quality role required. Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization) Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer) Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change Effective verbal & written communication skills in a cross functional environment with attention to detail Ability to present solutions to complex and strategic issues Evidence of commercial awareness in technical strategies Excellent customer focus with demonstrated management of customer expectations Effective presentation skills
Salary Range:
$80K -- $100K
Minimum Qualification
Life Sciences, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Provide Quality oversight of R&D activities Ensures bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP. Supports the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development. Reviews and approves executed batch records and development/validation/qualification protocols Ensures data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness. Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP) Authors phase appropriate FLQA procedures for oversight of clinical manufacturing activities Provides QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required Provides QA oversight to level 0 changes and minor deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations Supports the implementation of the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations, and identified areas for continuous improvement Establishes relationships with R&D QA and other global Quality functions:
Advises R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets Helps maintain the Quality System in R&D Identifies and escalates risks to compliance to senior management Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities Supports internal audits and helps prepare for regulatory inspections Supports inspection finding responses related to applicable area of oversight Supports the provision of accurate and timely reports on metrics, findings, risks and trends Minimum Requirements:
Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred. 3
years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry. Previous work in a QC, Research, Development, Manufacturing or Quality role required. Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization) Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer) Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change Effective verbal & written communication skills in a cross functional environment with attention to detail Ability to present solutions to complex and strategic issues Evidence of commercial awareness in technical strategies Excellent customer focus with demonstrated management of customer expectations Effective presentation skills
Salary Range:
$80K -- $100K
Minimum Qualification
Life Sciences, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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