QA Specialist II
QA Specialist II 197876
Are you energized by a Quality Assurance Specialist II role that allows you to accelerate compliance in a highly technical and regulated environment? If so, this Quality Assurance Specialist II role could be an exciting opportunity to explore.
As an Quality Assurance Specialist II, you will manage/lead/be responsible for supporting QA Operations to ensure the safety, quality and efficacy of product by providing support to customers in the Value Streams, Technical Operations and Quality Control.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Environment Health & Safety: Responsible for application of GSK safety and environmental guidelines.
- Quality & Compliance: Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
- Continuous Improvement: Continue support of continuous improvement culture 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 manners
- Batch Review: Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
- Quality Systems: Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, QA holds, Deviations, Technical Complaints/Adverse Events, Management Monitoring and Self inspection auditing, QA reporting and approval of GMP documentation.
- Quality Operations: Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.
- Investigations: May participate in review and approval for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
- Customer Support: Provide technical and quality operations support to respective departments. Provide on the floor QA support to manufacturing operations as needed.
- Other Duties as mandated by site priorities and Quality, Business, or Safety requirement
We are looking for professionals with these required skills to achieve our goals:
- High School Diploma or Equivalent
- 3 years of experience in a cGMP environment
If you have the following characteristics, it would be a plus:
- Associated Degree or Bachelor's degree with 1 year of experience
- Previous leadership experience is preferred
- Experience addressing technical business solutions
- Strong verbal and written communication skills
- Proven experience assuring compliance with regulations
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
This is a job description to aide in the job posting, but does not include all job evaluation details.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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