This job listing has expired and the position may no longer be open for hire.

QA Specialist II at GlaxoSmithKline

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: HAMILTON, Montana

Job Description:

QA Specialist II 197873

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

Why you?

Basic Qualifications:

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

Preferred Qualifications:

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

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

*This is a job description to aide in the job posting, but does not include all job evaluation details.


If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.