QA Coordinator

1 month ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Aug 2 2024

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment?

The purpose of the QA Coordinator position is to provide QA support to the site when implementing new products, review of records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems are in place and in use. This is done through direct intervention with other staff onsite in the facility. This role may develop, implement and administer input and in-process electronic quality systems for the production of biopharmaceutical products; ensuring compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role provides quality decisions to project teams and to production operating teams.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Review production and control records using established procedures and guidelines to support lot release of finished biopharm products.
  • Administer electronic systems using established procedures and guidelines to support lot release of biopharm products and intermediates.
  • Support special projects, such as validation, site priorities, or new product tech transfer, 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.
  • Collect and evaluate information to assist in internal and regulatory audits. May support or conduct internal audits and prepare summary reports.
  • Actively apply 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 equipment and process validation protocols, automation change controls, and computer validation.
  • Manages or supports closure of Quality system records including deviation investigations, corrective and preventative actions, and change controls.
  • 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:
  • Bachelor in Biology, Chemistry, Engineering, Biotechnology, or Computer Science
  • 1+ years' e xperience in biologics manufacturing
  • 1+ years' experience in quality systems (deviation, validation, documentation, change controls, or auditing/compliance)
  • 1+ years' experience with cGMP (current Good Manufacturing Practices) in pharma, testing, secondary repacking or similar field
  • This candidate has to be comfortable with being on site and have open availability to working the Day shift (5AM - 5PM) or night shift (5PM-5AM) depending on team needs.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • 3+ years e xperience in biologics manufacturing and quality systems, including validation, documentation, or auditing/compliance
  • 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

Please visit GSK US Benefits Summary t o 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 US Toll Free) or 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.

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