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Base pay range
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Director Delivery Services at LanceSoft, Inc.
Role: QA Associate
Location: Slough, Berkshire SL1 4DX
Duration: 9-month role with potential to extend
Fully onsite position
Description
Role Purpose & Scope:
* Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership.
* Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets.
* This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes, and escalating non-compliance through PQS, site governance mechanisms, and senior QA Leadership as needed.
* Support Senior QA leadership to drive continuous improvement.
* Maintain compliance with Regulatory Authorities requirements, Global Quality standards, and client’s Customer expectations.
Key Responsibilities
* Review documentation generated during manufacturing, development, and laboratory processes.
* Advise on best practices for document completion, review, follow-up actions, and escalation if required.
* Serve as a point of contact for general Quality queries and escalate as needed.
* Identify, report, and resolve non-conformances using GMP and quality procedures, including deviations and CAPAs.
* Participate in continuous improvement activities and mentor colleagues in cGMP practices.
* Maintain audit readiness and contribute to PQS process improvements.
Key Stakeholders
Interactions with:
* Manufacturing
* Material Science and Technology (MSAT)
* Supply Chain
Required Skills & Competencies
* Proficiency with MS Office and database management.
* Strong verbal and written communication skills.
* Risk-based decision making.
* PQS experience.
* Attention to detail and accurate data entry.
* Workload prioritization and decision-making skills.
* Ability to meet strict deadlines.
* Organizational and planning skills.
Education/Degree
* Bachelor of Science (or equivalent) in Biology or related field.
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance, Science, and Research
Industries
* Biotechnology Research and Pharmaceutical Manufacturing
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