Quality Assurance Specialist Iii

2 months ago

Royston, United Kingdom Precision for Medicine Full time

Due to our continued growth, Precision from Medicine have a current opportunity for a **Quality Assurance Specialist III** to join our laboratory team based in Royston, Hertfordshire.

Precision for Medicine develops assays and run global logistics using biomarkers to stratify patients, incomparably improving client's R&D efficiency and success. We handle every aspect of clinical trials from sites to biomarkers to diagnostics. Precision Medicine Group is the leading global provider of precision medicine research services and creative commercialization solutions for life sciences companies.

**Position Summary**:
The Quality Assurance Specialist III will provide advanced-level, hands-on support from a regulated systems perspective in a Good Laboratory and Good Clinical Practice (GLP /GCP) laboratory services. Activities include but are not limited to, internal (study, process, facility) auditing, and quality inspection, regulated study plan reviews, data, and report audits, in addition, this position is responsible for providing backup for the document and record control system. Extended work hours may be necessary to meet business demands.

**Essential duties include but are not limited to**:
Quality Function:

- Assist in maintaining established company-wide risk-based GLP/GCP Quality Management systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):

- Change Management
- Corrective and Preventive Action (CAPA)
- Deviations
- Supplier Quality Management
- Audit Programs
- Employee Training
- Document & Record Control
- Keep timely, organized, and accurate paper and electronic records. Be responsible for generation, protection, maintenance, accuracy, and integrity (quality control) of QA-related data and associated metadata.
- Maintain accurate data entry to all databases & shared systems.
- Provide advice and guidance on aspects of quality and compliance. Lead ongoing Good Practice efforts for the team, including clear and concise audit feedback, coordinating, and delivering ongoing GxP, quality and compliance training as required.
- Provide consultation to the operational team on quality issues,
- Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities.
- Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PfM, to include presentation of metric performance to management representatives and proposing durable solutions.
- Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies.
- Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing Subject Matter Experts for audit interviews.
- Act as a QA change-agent during continuous improvement and global harmonization efforts.
- Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints.
- Managing local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Ensuring Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
- To be aware and have a working understanding of the responsibilities of other members of the UK team and international QA team.

Operations Support:

- Support validation activities, including review and approve validation protocols, reports, and final package documentation.
- Assist in the QA review and customer specifications to conform to contractual requirements.
- Provide support to other departments regarding requests, regulatory requirements and other tasks as requested.
- Develop and distribute controlled quality system documentation.
- Work with functional groups to develop correct documentation required to document evidence for the laboratory processing, testing, and reporting.
- Perform area walkthroughs and audits for compliance to written expectations.
- Lead ongoing Good Practice efforts for the team, including clear and concise audit feedback, coordinating, and delivering ongoing GLP/GCP quality and compliance training as required.
- Be responsible for generation, protection, maintenance, accuracy and integrity (quality control) of QA-related data and associated metadata.
- Maintain and periodically review risk-based Quality Management System.

Miscellaneous:

- Participate actively on the safety committee, as needed.
- Participate in regulatory meetings and management review meetings as needed
- Assist in training new and existing personnel.
- Participate in regulatory, notified

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