Operational QA Coordinator

The Operational QA Coordinator will provide operational quality support to the site for new and existing products, review records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. These actions are executed through direct intervention between this role and other staff in the facility. This role may develop, implement, and administer input and in-process electronic quality systems for the production of biopharmaceutical products, ensuring compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role provides quality decisions to project teams and to production operating teams.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.
• Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.
• Support special projects, such as validation, site priority, or new products as required.
• Assist in data collection and preparation of trend analysis reports. Review for abnormal trends or indications of major problems.
• Ensure adherence to cGMP, CFR, and other governmental regulations in order to assure quality compliance.
• Performs review of documents related to change management such as work order review.
• Perform review of technical documents such as for equipment and process validation, automation and computer validation.
• This role may manage or support closure of Quality system records including investigations, corrective and preventative actions, and lab investigations
• Update departmental documents such as SOPs as required

Basic Qualifications:

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

• BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related STEM field.
• Experience in a biologics manufacturing or quality control and may include quality systems, including validation, documentation, compliance department.
• OR in Lieu of education, 2+ years of experience in a biologics manufacturing or lab setting which may include quality systems, including validation, documentation, compliance department.

Preferred Qualifications:

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

• The incumbent is responsible for adhering to all GSK safety guidelines and procedures.
• Good written communication, organizational, and computer skills. Good interpersonal and verbal skills required.
• Able to function within team-based organization.
• Able to prioritize and decide appropriate course of action.
• Effective decision maker.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, 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.

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 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/