System Support Specialist
Possession of a high school diploma or general equivalency diploma (GED), or years of related experience with Microsoft Word, Excel, Powerpoint, and Outlook, SAP, Expense Reporting, Click & Buy, and knowledge of Sharepoint, TechShare, quality management systems, and GMP industry management in lieu of a degree.
Ability to work on assignments that are complex in nature, in which independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Attention to detail: Management of validation documentation require attention to detail and follow up with user groups to ensure accuracy and understanding of documentation types.
Responsible for providing technical, compliance and organizational support to management of Quality and MSAT operations through validation document management, filing, archiving, QMS compliance, risk and change management. Comply with instructions on standard operating procedures and batch documents. Ensures schedule adherence to meet GMP compliance. Actively promotes the success of the site through continual collaboration across departments. Responsible for providing technical, compliance and organizational support to management of Quality and MSAT operations through validation document management, filing, archiving, QMS compliance, risk and change management. Comply with instructions on standard operating procedures and batch documents. Ensures schedule adherence to meet GMP compliance. Actively promotes the success of the site through continual collaboration across departments.
Management of validation documentation for the site and electronic system used to store documentation.
Support compliance and readiness for internal and external inspections and provide adequate support to inspected departments.
Participate as member of cross functional team to investigate deviations.
Develop, author and modify departmental LSOP's as needed in support of daily operations and implement OE initiatives within primary area of responsibility.
Ensure compliance to GSK policies and procedures.
Support internal, external global and regulatory agency audits as subject matter expert of the validation document management system.
Assist with the organization, preparation and presentation of MSAT topics during internal and third party audits.
Assist with corrective actions impacting area of responsibilities.
Promote Safety within the team. Provide positive reinforcement for good practice and escalate issues that require attention or improvement.
Provide timely escalation of complex and difficult problem solving issues to cross-functional teams for investigation.
Compliance to good documentation practices and "right the first time".
Escalate issues that could present a cGMP noncompliance or an unsafe work environment.
Possess a work ethic that includes neatness, punctuality, thoroughness and accuracy.
Support electronic system implementation in areas of responsibility (e.g., improvements to manage of validation documentation system electronically).
Assist with administrative assistant duties across the site. Organizing lunches, meetings and travel for managers of MSAT and Quality organizations.
Support and positively impact production operation OE goals and objectives.
Will be adept at working both as an individual and in varying groups in a dynamic, multi-tasking environment.
Will have the ability to prioritize and flexibility to adapt to changing business schedules and deadlines
Will have the ability to take initiative and work proactively with creative problem solving skills.
Follow defined methodology and standards including preparation, review and maintenance of GMP documentation for all stages of work.
Distribute/archive of MSAT & Quality department SOP's and GMP documentation.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.
Meet Some of GlaxoSmithKline's Employees
Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.
Back to top