QA Systems Specialist

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:

• Bachelors 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:

• 1+ years’ experience of quality systems
• Master’s degree
• 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 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.

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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.

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