Hobson Prior are looking for a GCLP QA Associate to join a biopharmaceutical organisation where you will have a unique opportunity to join an exciting start-up phase that has the ability to transform the clinical management of cancer. This position will be on a permanent basis to be located in Stevenage.

Job Responsibilities:

• Offer QA support for GCLP activities for the company's Translational Science team.
• Provide QA support for GCLP associated Quality System Documents such as but not limited to Deviations, Change Controls, Corrective and Preventative Actions and Audits.
• QA Review of GCLP laboratory worksheets and reports, as required.
• Review and approval of documentation including but not limited to Standard Operating Procedures, policies and forms, ensuring compliant templates used (as required), formatting, considering usability, accuracy, consistency and quality.
• QA support for GCLP assay activities, according to regulatory guidelines.
• QA support for laboratory set up and transfer including equipment qualification activities, as required.
• Verify completion of actions from Quality System Documents such as Deviations, Change Controls, CAPAs, Audits and update relevant Quality Logs, as required
• Coordinate GCLP Training requirements with key stakeholders to deliver training plans
• Provision of associated in house QA training activities for GCLP team, as required
• Deliver GCLP training for new starters, and refresher training for existing staff.
• You will assist with GCLP regulatory inspection preparation activities and follow-up activities as required.

Key Skills:

• Ability to work as part of a team.
• Strong attention to detail including accuracy and completeness of records.
• Ability to review and critique GxP documents and data.
• Can work consistently, flexibly and independently.

Requirements:

• Scientific Degree - B.Sc. or M.Sc. or equivalent in Chemistry, Biology, Biomedical Sciences or Pharmacy or closely related subject.
• Minimum of 3 years' experience working in a regulated environment ideally with QA and Laboratory background.
• Minimum of 2 years' experience working in a GCLP or GLP laboratory.
• Experience with laboratory equipment qualification and assay validation activities.
• Experience in reviewing and critiquing GxP data and documentation.
• A good understanding of the regulatory expectations, standards and associated framework that applies to GCLP, Clinical bioanalysis or closely related fields.
• Good understanding of Good Clinical Laboratory or Good Laboratory Practice and Quality Assurance principles.
• Experience in reviewing and/or writing SOPs/WIs/forms that form part of a Quality Management System.
• Experience in working within a high paced and dynamic environment.
• Experience of training staff.
• Significant working knowledge of Microsoft office suite including Word, Excel and PowerPoint.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.