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QA Coordinator

Company: GlaxoSmithKline LLC
Location: King Of Prussia
Posted on: June 25, 2022

Job Description:

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this QA Coordinator role could be an ideal opportunity to explore.As an QA Coordinator, you will be responsible for providing support to the site when implementing new products, reviewing of records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. This is done through direct intervention between this role and other staff in the facility. This role may develop, implement and administer input and in-process electronic quality systems for the production of biopharmaceutical products ensure compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role will act as advisor, facilitator and team member regarding regulatory compliance and quality systems for all aspects of manufacturing of biopharmaceutical products. This is done through direct intervention between this role and other staff in the facility. This role provides quality decisions to project teams and to routine operating teams. This position will provide guidance and training to new and existing employees in the Quality Assurance department and assist them with decision making.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Collect and evaluate information to assist in internal and vendor audits. May support or conduct internal audits and prepare summary reports. Manage vendor lists.Review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods. Support special projects, such as validation, site priority, or new products as required.Supports and/or assures completion of annual product reviews. Assist in data collection and preparation of trend analysis reports. Review for abnormal trends or indications of major problems.Advanced knowledge in cGMP, CFR and other regulations in order to assure quality compliance.Performs review of documents related to change management such as work order review.Perform review of technical documents such as for equipment and process validation, automation and computer validation.Manages or supports closure of Quality system records including investigations, corrective and preventative actions, and change control.Update departmental documents such as SOPs as required.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related field Or Sufficient technical depth or professional experience will be considered in lieu of technical degree. 1+ year industrial experience in quality organizations, either in operations or assurance functions. Quality control potentially1+ year experience knowledge of cGMP in the regulated industry of pharmaceutical production and supplyPreferred Qualifications:If you have the following characteristics, it would be a plus:Experience in quality systems, including validation, documentation, compliance department preferred.The incumbent is responsible for adhering to all GSK safety guidelines and procedures.Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements preferred.Good written communication, organizational, and computer skills. Good interpersonal and verbal skills required. Able to function within team based organization.Able to prioritize and decide appropriate course of actions. Effective at implementing decisions. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.Why GSK?At GSK, we have already delivered unprecedented change over the past four years, improving R, 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 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-GSKIf 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/ AgenciesGSK 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.

Keywords: GlaxoSmithKline LLC, Philadelphia , QA Coordinator, Other , King Of Prussia, Pennsylvania

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