Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


GlaxoSmithKline (GSK)

QA Release Supervisor

Pharmaceuticals

All

Full Time

On Site

No

Cambridge, Massachusetts, United States

Site Name: Cambridge Binney Street
Posted Date: Jan 25 2024

GSK is currently looking for QA Release Supervisor to join our team in Cambridge, MA. The QA Release Supervisor is focused on support of releasing lots of internal GMP manufacturing to ensure compliance with all applicable regulations. This is a unique opportunity for an individual to work in a clinical/commercial stage Quality department and gain experience in many areas of Quality Assurance. The QA Release Supervisor will report to our Associate Director of Quality Assurance.

KEY RESPONSIBILITIES:

  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
  • Act as the Quality Assurance subject matter expert for questions and issues related to product release and SAP utilization for release activities.
  • Key contact for internal departments for lot release activities, liase with other sites (i.e QP) to ensure all applicable documentation is received for release activities
  • Release internal GMP manufacturing lots per standard operating procedures
    • Ensure accurate and timely release of produced lots in SAP and/or paper based systems
    • Maintain visibility to produced material as it progresses through SAP and/ or paper based systems
    • Escalating known issues that will hold product from release
    • Ensuring consistent data packages for release- verifying completeness of documentation- ensuring 100% clarity on releasability of a lot
  • Support master batch records, ensuring adherence to GSK internal procedures, policies, standards and FDA regulations
  • Assist with impact assessment of site product deviations
  • Support executed batch record review, when needed, to support lot disposition activities
  • Review and approve quality systems (i.e deviations, CAPAs, change controls) in support of lot release
  • Local owner for SOPs on release of internal manufactured lots

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in Chemistry, Biology, Engineering or related field
  • 8+ years of industry experience in pharma/biopharma
  • 5+ years of QA experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Experience with vaccines/biologics
  • Experience with Good Documentation Practices including Batch record review
  • Experience with review and disposition of clinical materials for human use
  • Experience with SAP
  • Knowledge of regulatory requirements
  • Able to respond to changing priorities and expectations with a composed demeanor
  • Ability to foster effective relationships with vendors and colleagues
  • Excellent communication, writing and presentation skills for interfacing with internal and external organizations
  • Strong collaboration and team skills
  • Ability and desire to work in a fast-paced environment
  • Ability to think through the process and accurately apply and adapt regulatory standards
  • Helpful to understand the QA function with the ability to make decisions on a go / no go criteria
  • The ability to work effectively within a variety of situations and adapt enthusiastically to changes in job demands
  • Pursues tasks with energy, drive, and initiative; even in a fast-paced environment
  • Comfortable in a results-driven, highly accountable environment where you can make an impact
  • Builds productive working relationships across key groups
  • Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure

#LI-GSK

Please visit [Register to View] to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 positively impact the health of 2.5 billion people by the end of 2030.

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-[Register to View] (US Toll Free) or +1 [Register to View] (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 [Register to View] site.