Job Description

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment?  If so, this Quality Standards Analyst role could be an ideal opportunity to explore.

As a Quality Standards Analyst, you will be responsible for investigating and trending consumer product quality complaints; supporting the site Periodic Product Review (PPR) process, QMS implementation activities, the site documentation lifecycle, and Quality initiatives/projects and/or supporting the site stability program.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Perform consumer product quality complaint investigations and liaise with operations in the identification of CAPAs.
Escalate to management increase of complaint types and/or thresholds.
Support maintenance of the site PPR Schedule and adherence to required timelines.
Support development and execution of training program governing the site’s PPR process.
Escalate to management trends or concerns identified through the PPR process.
Support the site stability program including stability sample management, identify trends, support product submissions and PPRs
Escalate to management adverse stability trends.
Support implementation and sustainment of the GSK Quality Management System (QMS).
Champion the document retention policies and provide advice to site users.
Issue site GMP documentation such as logbooks and notebooks.
Archive site GMP documentation as appropriate.
Interact with external documentation storage suppliers during audits and complex investigation for timely retrieval of information.
Work across multiple value streams to drive continuous improvement and promote quality culture. Utilize and continuously improve the GPS standards (i.e. 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste
Author and Review GMP related documentation such as procedures and work instructions.
Support site Self-Inspection, Internal Business Monitoring (IBM) audits and Inspection Readiness efforts.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor’s degree in Science, Engineering or similar.
3 years of experience in pharmaceutical or similarly regulated industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
Demonstrate initiative and analytical problem-solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level.
Project management skill and leadership skills.
Ability to work well under high pressure and deadlines
Flexible, adaptable, and a strong team player and leader
Excellent verbal and written communication skills
Conflict resolution and interaction management skills

Why GSK?

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.