QA Systems Specialist

1 month ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Aug 7 2024

The Quality Systems Specialist will develop, implement and administer input into in-process quality systems and/or 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 and testing 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 Systems 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:
  • Act as site Change Control Process Owner by working with change owners at the site, attending Change Control CoP calls, and acting as a change control process SME during audits.
  • Perform and /or manage review of production and control records using established procedures and guidelines.
  • Lead special projects, such as quality improvement initiatives.
  • Lead and Support internal audits (Level 1/Level 2) and prepare summary reports. Collect and evaluate information to assist in internal and vendor audits. Support L3/L4 inspections in various functions ranging from control room lead/support, scribe, SME.
  • Assure completion of annual product reviews. Review for abnormal trends or indications of major problems. Alert all relevant parties of the situation.
  • Advance knowledge in cGMP, CFR and other regulations in order to assure quality compliance.
  • Manages and support closure of Quality system records including corrective and preventative actions, change controls. Provide weekly/monthly site Quality and KPI metrics.
  • Update departmental documents such as SOPs as required. Perform the review of technical documents for equipment and technical terms of supply documentation.
  • Attend meetings as a Quality representative and provide input as required.
  • Support implementation of global strategies as required by the GSK business.
  • Quality representative for the delivery of Quality ILT trainings as needed
  • Additional responsibilities could include: supporting regulatory assessments, contributing and owning a PPR, conducting QRI, supporting pharmacopeial review, and assisting other quality systems


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree
  • 1+ years' experience of change control systems. Owning notifications or the system
  • 3+ years' experience in the pharmaceutical or biopharma industry


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree
  • 1+ years' experience of quality systems
  • ERP or SAP experience
  • Regulatory exposure and/or experience
  • Veeva experience
  • 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 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, 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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