Quality Control Senior Specialist

GlaxoSmithKline
United States, Montana, Hamilton
553 Old Corvallis Road (Show on map)
Nov 21, 2024
Site Name: USA - Montana - Hamilton Posted Date: Oct 14 2024 The Quality Control Senior Specialist will perform routine QC laboratory activities to support the manufacture and release of products and incoming materials. Understand test equipment and scientific principles of methods within the scope of their responsibility. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Perform testing following written methodologies and report results which are clear, defensible and right the first time. Demonstrate awareness of the scientific principles and method validation for the assays which they perform. Review GMP assay data and communicate findings to manufacturing teams. Prioritize and decide appropriate course of action with minimal supervision. Lead lab investigations Coordinate and schedule preventative maintenance activities with external vendors Perform revision of standard operating procedures, act as Process Owner for applicable methods. Train/teach team members on applicable procedures Serve as subject matter expert on various methods/topics Coach other members of team and influences situational adaptability across department Support non-routine tests, studies or projects Support the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state. Escalate issues associated with equipment and assays as required. Understand and comply with current GMP regulations and quality systems. Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices. Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions Responsible for application of GSK safety and environmental guidelines and identification, escalation and prevention of safety issues. Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas. Annual training on area-specific hazardous waste handling is required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site's RCRA compliance program. Assist in maintaining area of responsibility in a state of inspection readiness Performs other departmental duties as assigned by management Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in a scientific discipline 2+ years of experience in a GMP lab setting Physical requirements include stooping, standing, climbing and occasional lifting of up to 50 lbs Preferred Qualifications: Chromatography experience 5+ years of experience in similar role Computer skills and knowledge; basic proficiency with Microsoft Office programs. Demonstrated ability to work successfully both independently and in a team environment Good verbal and written communication skills Good time management skills #LI-GSK #LI-Onsite #EarlyCareers 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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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. 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