Qa Specialist Ii Jobs

Site Name: Cambridge Binney Street
Posted Date: Aug 3 2023

This role qualifies for an enhanced Employee Referral Bonus in the amount of $3,500. In order to be eligible for an Employee Referral reward, you must be an employee working at GSK. Please refer to your local country policy for eligibility requirements and guidelines.

Are you energized by a highly visible role that allows you to influence stakeholders and shape highly effective business partnerships? If so, our QA Operations Specialist II role could be an excellent opportunity to explore!

As a QA Operations Specialist II, this role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Execute all activities following quality and regulatory standards and procedures.
• Continue support of continuous improvement culture and industrial excellence methodologies.
• Promote a quality mindset and quality excellence approach to all activities.
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
• Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Support employees and respective departments in a manner which is clear in approach, communication, and action.
• Provide on the floor QA support to manufacturing operations.
• May participate in review and approval for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
• Responsible for application of GSK safety and environmental guidelines.
• Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.

Why you?

Basic Qualifications:

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

• Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: testing, equipment / facility maintenance, validation, and calibration systems.
• HS Diploma or equivalent and 6+ years of experience in a cGMP environment, OR associate degree and 4+ years of experience in a cGMP environment, OR bachelor’s degree and 2+ years of experience in a cGMP environment.

Preferred Qualifications:

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

• Ability to prioritize and the flexibility to adapt to changing priorities.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC.
• Ability to work on multiple projects on a tight timeline.
• Vaccines experience a plus.
• Able to prioritize and decide appropriate course of actions.
• Experience working successfully both independently and in a team environment.
• Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
• Root cause analysis experience preferred.
• Demonstrated experience in regulatory inspection activities.
• Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.

Why GSK?

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

#GSKBinneyStreet

#LI-GSK

#GSKAffinivax

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. 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 1-877-694-7547 (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.

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.