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Quality Control Analytical Support Team Specialist

King of Prussia, PA
Closing date
May 15, 2022

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Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 25 2022 Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Quality Control Specialist role could be an exciting opportunity to explore. The Quality Control Specialist provides support to the QC laboratories by performing such duties as data review, lead investigator for deviations, aid in scheduling, equipment adminstrators, drive continuous improvement projects, change management, equipment management and compile and report metrics. This role is important to the QC department for the support it provides to the analysts which allows for targeted turn around times of results to be met for timely batch release. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Oversees the effective analytical planning and scheduling of testing, maintenance, and any other manufacturing process impacting activities in the building. Initiates Deviations as needed and facilitates investigation. Monitors and report quality metrics. Identifies optimization opportunities in Quality Control by owning Change controls and CAPA tracking. Author or revise documents for compliance, accuracy and clarity. Troubleshoots operational problems with equipment and other systems (LES etc..) Performs review of analytical data to support batch release and CoA/ RoA creation. Familiar with Data integrity principles and looks for improvements to eliminate or reduce DI issues. Supports implementation of new products in the facililty (BAU process and Data maintenance) Performs routine departmental GMP activities (routine work orders, sample chain of custody, audits) Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors Degree in Biology, Biochemistry, or equivalent 5 + years manufacturing experience and/or experience in the pharmaceutical or Biotechnology industry. Preferred Qualifications: If you have the following characteristics, it would be a plus: Able to demonstrate a high level of technical and leadership skills. Strong Leadership skills Strong communication skills Basic understanding of cGMP Lead change projects with compliance in mind Applying ALCOA principles when performing operations or reviewing analytical data Ability to work indenpendently as well as being able to work collaboratively with others on projects Experience with various systems such as: SAP, LES, Empower Familiarity with BI reports, Root cause analysis and EDM Gathering data from various systems and creating metrics Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK #globalsupplychain 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.
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