GlaxoSmithKline Consumer Healthcare, L.P. QA Senior Specialist in Hamilton, Montana
Site Name: USA - Montana - Hamilton
Posted Date: Feb 12 2021
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 QA Senior Specialist role could be an ideal opportunity to explore.
As QA Senior Specialist, you will be responsible for QA Systems Specialist work such as Potential ownership of Quality systems for change control, deviations and CAPAs.You will also provide additional support in QA validation such as Validation and Qualification support for new systems, equipment, processes and infrastructure related to adjuvant manufacturing. You will support operational QA to ensure the safety, quality and efficacy of product by providing support to customers in the production value streams (commercial and product-related), Quality Control, Technical Services (e.g. Facilities, Engineering and Calibration) and the Validation team. You will be involved in Coaching and Mentoring of site in order to promote a solid Quality Mindset and understanding of both Patient Safety and Regulatory Compliance.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Quality Systems: may be responsible for management of the following major quality systems: Change control, CAPAs, Deviations. Management of systems includes reporting and training as necessary.
Quality: supports GMP compliance and inspection readiness within organization.
Investigations: may be responsible for performance, review and approval for investigations associated with complaints, deviations, CAPAs, Out of Specification, Out of Tolerance, Atypical results.
QA Validation review: Review validation and qualification documents for QA content, Compliance, and Regulatory impact
Environment Health and Safety: responsible for application of safety and environmental guidelines
Quality and Compliance: execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
Continuous Improvement: Champion a culture of continuous improvement, and industrial excellence methodologies.
Accountability: support employees and respective departments in a manner which is clear in approach, communication and action. Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all matters.
Why you?Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
At least 5 years' experience in cGMP pharmaceutical environment or related industry focused on quality operations. (can be substituted in specific cases e.g. FLP candidates).
Understanding of regulatory requirements and the technical aspects of the manufacture of a pharmaceutical or vaccine product is important when managing these systems.
Understanding of regulatory requirements for quality systems is important to manage the quality systems for the site.
If you have the following characteristics, it would be a plus:
Use and understanding of SAP system, Microbiology Background, have Chemistry Background, Automation or Automation Engineering Experience.
Demonstrate experience and working knowledge of cGMPs and associated regulatory requirements and guidelines for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products required.
Significant understanding of US and European GMP regulations.
Strong verbal and written communication skills.
Experience of working successfully both independently and in a team environment, with minimal supervision and back-up supervisor when needed.
Experience of interacting with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
Our values and expectationsare 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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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