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Operational QA
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King of Prussia, PA (In Person)
Full-Time
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Job Description
Operational QA
King of Prussia, PA
5 DAYS AGO
22708980
Summary
King of Prussia, PA
In-Person
Competitive Salary
5 Years Experience
Bachelor's degree
No Commission
40.00 hours per week / Day Shift / Full-Time
Description The Operational QA will perform the quality assurance activities and quality oversight for the manufacturing of Drug Substance at Upper Merion R D Pilot Plant.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and incorporate effective processes and procedures in Quality R D Operations for Drug Substance and Cell Banking manufacturing. Approve GMP documentation, including Standard Operating Procedures, pre and post approve batch records, validation documentation, change controls, and other controlled documents from business partner areas. Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Quality R D and business units regionally and globally. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. And other duties as assigned Why You?
Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree 5+ years of experience in Quality roles OR in a highly regulated environment (EMA/ FDA/ MHRA) and manufacturing operations Large Molecule experience Preferred Qualification If you have the following characteristics, it would be a plus: Problem solving and negotiation skills Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest Ability to drive change and continuous improvement Ability to communicate complex information both orally and in writing Fluency in English both written and spoken Problem solving and negotiation skills Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest Ability to drive change and continuous improvement Ability to communicate complex information both orally and in writing Fluency in English both written and spoken #LI-GSK Please visit GSK US Benefits Summary to 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and incorporate effective processes and procedures in Quality R D Operations for Drug Substance and Cell Banking manufacturing. Approve GMP documentation, including Standard Operating Procedures, pre and post approve batch records, validation documentation, change controls, and other controlled documents from business partner areas. Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Quality R D and business units regionally and globally. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. And other duties as assigned Why You?
Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree 5+ years of experience in Quality roles OR in a highly regulated environment (EMA/ FDA/ MHRA) and manufacturing operations Large Molecule experience Preferred Qualification If you have the following characteristics, it would be a plus: Problem solving and negotiation skills Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest Ability to drive change and continuous improvement Ability to communicate complex information both orally and in writing Fluency in English both written and spoken Problem solving and negotiation skills Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest Ability to drive change and continuous improvement Ability to communicate complex information both orally and in writing Fluency in English both written and spoken #LI-GSK Please visit GSK US Benefits Summary to 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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