Senior Quality Associate - Preclinical & Laboratory Quality

CSL•Waltham, MA

1d•$94,000 - $111,000

About The Position

Preclinical laboratory QA Staff (Advisor) ensures compliance to GLP, GCLP (ISO/IEC 17025), GRLP and other GxP requirements (as applicable). This role will support the implementation of GLP/GCLP quality initiatives, systems, and processes across the relevant R&D Preclinical and clinical lab functions at defined sites, while advancing globally harmonized phase-appropriate quality strategies for research, pre-clinical, and clinical stages of product development. Role will support maintenance of robust quality systems, lead inspection readiness activities, manage regulatory inspections, and follow up on quality actions including corrective and preventive actions (CAPA) to ensure timely and compliant resolution of findings. This role models the CSL Way and promotes a strong quality culture aligned with organizational vision and values to bring durable improvements in quality systems and processes.

Requirements

BS Degree in relevant biological science, science, or related discipline.
Minimum 3 years’ experience in at least one of: working in laboratories under GLP/GxP conditions, Quality Assurance or relevant process development facilities.
Experience in one of the following: R&D Quality (GMP or GLP) and/or product development teamwork.
Knowledge of OECD Principles of GLP.
Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements.
Experience and knowledge in the application of Quality Systems.
Commitment to improvement.
Strong planning and organizational skills.
Good presentation, negotiation, and decision-making skills.
Strong customer focus.

Responsibilities

Work with R&D partners and stakeholders to establish procedures, standards, and systems according to local and regulatory standards including liaising with R&D departments regarding quality assurance and compliance related issues.
Ensure compliance with documentation relevant to GLP and ISO 17025 compliance is maintained.
Review and approve final study plans/protocols and study reports for compliance with the OECD Principles of GLP; manage QA statements for GLP studies to be included in final study reports.
Plan and conduct ISO 17025 inspections as well as general GLP process inspections, facility inspections, study inspections and document inspections to determine if all studies are conducted in compliance with the OECD Principles of GLP: report inspections findings and improvement recommendations to relevant departments in efforts to maintain regulatory compliance and continuous improvement.
Ensure all inspection findings are reported to Test/Site Facility Management and Study Director and Principal Investigator as applicable to relevant departments.
Review clinical and pre-clinical assay method development documentation.
Review equipment validation documentation.
Support relevant departments during GLP/GCLP regulatory inspections.
Support regulatory compliance with OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
Manage, facilitate and risk assess R&D deviations and change controls for implementation.
Liaise with R&D departments and other key stakeholders regarding quality related issues with deviations, change controls and audits.
Provide QA and compliance support for new applications and information requests associated with facilities & permits for regional regulators Dept of Agriculture.
Support key performance metrics reporting (as needed).