Distribution Quality Specialist

Glaxosmithkline Fresno , CA 93707

Posted 4 weeks ago

Site Name: USA - California - Fresno

Posted Date: Mar 5 2020

As a Distribution Quality Specialist you will be responsible for providing effective and efficient support to the Local Operating Company (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.

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

  • Provide Quality support on Logistics and Display and Packaging related activities within the supply chain to assure quality of GSK CH products during packaging and distribution. Ensure that operations performed by the third party labor provider(s) and Logistics Service Providers and Distributors comply with the requirements of the GSK QMS and meet all relevant GMP/GDP regulatory and legislative requirements.

  • Ensure GSK CH Logistic activities comply with GDP for products received, inspected, stored, handled, and further distributed by GSK. Perform release-to-market activities in SAP involving confirmation of batch release, temperature monitoring evaluation, and reconciliation of product quantities.

  • Provide support to the Quality Distribution & Logistics Manager in the continuous improvement, harmonization, and establishment of Quality systems. Support warehouse and distribution facilities, operations, contract operations, logistics, product/process improvements, eliminate barriers, and investigate quality issues using applicable process improvement and problem-solving techniques to assure successful outcomes of audits and Health Authorities inspections in all assigned sites/companies.

  • Provide Quality oversight and support for display packs & repackaging activities, performing compliance-related aspects such as review/approval/release to market, review and approval of validation activities, taking part in project teams, and maintaining business continuity in a seamless, compliant manner.

  • Work with the business partners to ensure that the Quality activities within the distribution chain operate in a cost-effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice while maintaining appropriate levels of quality and compliance.

  • Assist Quality Logistics & Distribution Manager in the implementation of GSK CH Quality standards and cGMP requirements within assigned Display and Packaging and Regional Distribution Centers and Logistics Service Providers.

  • Serve as backup to the Quality Logistics & Distribution Manager in supporting Logistics and Display and Packaging activities. Problem solve and provide support to third party laborers performing Display & Packaging activities.

  • Remain current on new regulations related to Distribution and Logistics and training requirements, ensuring activities are performed compliantly.

  • Provide suggestions for resolution of quality issues impacting logistic operations to the Quality Logistics & Distribution Manager, ensuring issues requiring formal escalation are brought to the Quality Logistics & Distribution Manager's attention within established timeframes.

  • Ensure that investigations, effective CAPAs and change controls associated with Logistics, Distribution and Display and Packaging facilities are properly performed, documented, evaluated, and closed timely as per procedures.

  • Assist the audit team in audit preparation and participate in the audit execution of assigned warehousing and distribution facilities

  • Review, approve and release display packs ensuring strict adherence to cGMPs. Ensure non-conformances discovered during review are identified and escalated appropriately.

  • Assist the Quality Logistics & Distribution Manager as needed in activities such as Quality Agreement implementation, recall activities, audit commitment activities, self-inspections, and inspection readiness activities.

  • Perform written gap analyses of relevant QMS documents to SOPs and make appropriate corrections to increase compliance.

  • Provide support for all display and packaging related activities as it relates to quality.

  • Manage temperature excursions which occur during shipping

  • Perform release-to-market activities, with ability to communicate effectively with sister distribution centers and business partners.

Why you?

Basic Qualifications:

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

  • High School Diploma
  • 1-2 years prior experience in a related role in the Pharmaceutical or Consumer Healthcare industry

Preferred Qualifications:

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

  • Associate's degree

  • GMP/GDP knowledge and ability to identify and ensure resolution of compliance issues

  • Operational Quality experience

  • Problem identification and solving skills

  • Good leadership skills

  • Excellent oral and written communication skills

  • Strong interpersonal and negotiation skills

  • Customer service oriented

  • Ability to enable and drive change and continuous improvement

  • Able to work effectively in English

  • Self-starter, able to schedule and progress workload on own

  • Good time management skills, with ability to multi-task and work under pressure

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness.

  • This is a job description to aide in the job posting, but does not include all job evaluation details.

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.

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.

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Distribution Quality Specialist