QA Specialist II

Site Name: USA - Montana - Hamilton Posted Date: Feb 4 2023 As a QA Specialist II, you will 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. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 702. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Responsible for application of GSK safety and environmental guidelines. Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities. Continue support of continuous improvement culture and industrial excellence methodologies. 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 Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. 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. 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. 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. 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: 3+ years of experience in a cGMP environment OR 1+ year(s) of experience in a cGMP environment and an Associate's/Bachelor's Degree Preferred Qualifications: Bachelor of Science or Bachelor of Arts degree in a scientific discipline. Previous experience working with quality systems having oversight of cGMP production operations, testing, equipment / facility maintenance, validation, and calibration systems. Demonstrated experience in regulatory inspection activities. Ability to work on multiple projects on a tight timeline. Ability to prioritize and the flexibility to adapt to changing priorities. Experience in the use of Lean Six Sigma and statistical tools. Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets. Demonstrated ability to work successfully both independently and in a team environment. Strong verbal and written communication skills. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC. Able to prioritize and decide appropriate course of actions.
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Vaccinessupplychain Why GSK? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 Get Ahead 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.