Senior Laboratory Auditor, Lab QA - Open to flexible working, homeworking
- Contract Type
GSK are looking for a Senior Laboratory QA Auditor to join site in Stevenage on a full-time and permanent basis. This role will be based on site but will have some flexibility working from home. Prior to location at the Stevenage site there could be a short period working at the Ware site.
To perform GLP and GCP quality assurance activities in GSK laboratories and / or external laboratories. To assess GSK and external laboratories and providers for human biological sample requirements. To assess non-regulated GSK laboratories for quality and compliance with Written Standards. To provide compliance support through advice and consultancy to GLP and clinical laboratories and related supporting functions in GSK.
There will be a small amount of travel required for this role across the UK, within Europe and possibly to the Far East.
- Lead or assist in internal facility audits of GCP laboratory work.
- Lead or assist in audits of External Service Providers (national and foreign based) that are engaged in GLP work and / or the analysis of samples from clinical trials.
- Lead or assist in audits / inspections of human tissue use activity within GSK facilities and external facilities.
- Conduct inspections of procedures and review documentation associated with the analysis of samples from clinical trials
- Manage workload such that internal and external QA activities are completed on time while balancing other high priority activities such as regulatory inspections
- Develop and implement effective processes and procedures in Global Quality Assurance (GQA) and may contribute to business processes and procedures outside GQA.
- Monitor for compliance with regulatory requirements; report the nature and severity of noncompliance.
- May interact with regulators.
- May lead a project, program or team activities.
- May be responsible for coaching, mentoring, training, or directing activities within GQA and R&D
- Identify business or reputational risks and communicate these upward along with suggestions for risk management solutions.
- Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
- Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
- May represent Lab QA as a primary business contact for specific areas.
- Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
- Communicate and interact at various levels internally and externally to GSK.
- Build and maintain effective internal GSK business relationships within GQA and business units.
- Author/review Lab QA quality documents (e.g. SOPs, Guidance Documents).
Closing Date for Applications: Thursday 6th May 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
- Experience of working in a Quality or Scientific role
- Strong verbal and written communication skills
- Interpersonal skills with negotiation and influencing
- Planning, organization and on-time delivery
- Strong Report Writing skills
- Auditing electronic and paper data / records
- Computer skills including MS applications
- Degree Qualified in a Scientific subject
- Experience in Quality Assurance is desirable
- Knowledge of GCP (in the laboratory) and/or GLP
- Knowledge of management of human biological samples
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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