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Senior Quality Assurance Specialist - 2nd Shift
Location:
Hamilton, MT
Description:
The Senior Quality Assurance Specialist - 2nd Shift will represent operational QA to ensure the safety, quality and efficacy of product by providing direct 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 teams. Coaching and Mentoring of site personnel in order to promote a consistent Quality Mindset and understanding of both Patient Safety and Regulatory Compliance will be paramount in this role. The incumbent will support manufacturing operations across two shifts to mimic the Manufacturing schedules and to ensure a consistent Quality Mindset for all teams as GSK Hamilton. There will also be opportunity to support Validation and Qualification activities for new systems, equipment, processes and infrastructure related to adjuvant manufacturing as needed and assigned. Please note this position may be for current hiring needs as well as pipelining potential talent for future vacancies. Communication may be limited until we have initiated an official recruitment process for this position. We appreciate your patience and hope to be in contact soon. Shift Schedule (subject to change based on business needs): 2nd Shift -- Schedule: Monday/Tuesday/Wednesday/Thursday -- 4:00pm - 3:00am 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's Degree in Scientific Discipline and 3+ years of experience in a cGMP regulated environment OR, Associates degree in a scientific field with 5+ years pf experience in a cGMP regulated environment with Quality Assurance experience OR, High School Diploma or equivalent with 7+ years of experience in a cGMP regulated environment with 3+ years as part of the Quality Assurance function Preferred Qualifications: Bachelor's Degree with specialization in Computer Validation or QA for Computerized Systems5+ years experience in cGMP pharmaceutical environment or related industry focused on quality operations Demonstrated 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. Ability to work successfully both independently and in a team environment. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC. Use and understanding of SAP system. Microbiology Background Chemistry Background Automation Automation Engineering Experience #LI-GSK#LI-Onsite#secondshiftPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-XXXX (US Toll Free) or +1 801 567 XXXX (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.PDN-9c0bcec1-06c8-4bd9-90b6-d3f157a9c98e
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More About this Listing: Senior Quality Assurance Specialist - 2nd Shift
Senior Quality Assurance Specialist - 2nd Shift is a Quality Assurance QA Specialist Job at GSK located in Hamilton MT. Find other listings like Senior Quality Assurance Specialist - 2nd Shift by searching Oodle for Quality Assurance QA Specialist Jobs.
Senior Quality Assurance Specialist - 2nd Shift is a Quality Assurance QA Specialist Job at GSK located in Hamilton MT. Find other listings like Senior Quality Assurance Specialist - 2nd Shift by searching Oodle for Quality Assurance QA Specialist Jobs.