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Value Stream Manufacturing Technical Expert - Purification

Company: GSK
Location: Hamilton
Posted on: April 5, 2021

Job Description:

As a Value Stream Manufacturing Technical Expert, you will perform duties as assigned with respect to quality, timeliness, quantity, and cost. Work individually and as a team to deliver cGMP compliant product. - Adhere to GSK policies, procedures and support site goals. -Complete documentation in line with regulatory, GSK, and departmental requirements. -Work and communicate closely with other departments both inside and outside of the Value Stream. Train and mentor less experienced staff. -Work with minimal supervision and coordinate complex tasks between departments. -Oversee and coordinate equipment related task and issues. -Demonstrate ability to cross train in multiple disciplines across the Value Stream and participate in cross functional teams. Take initiative, provides accurate "right the first time" work and practices good time management in a fast paced, ever changing environment. Demonstrate an in-depth knowledge of the job. -Assist in resource planning, organization and control of activities and produces a high quality and high volume of work. Act as the SME person for questions about the process or equipment in the area of responsibility including interacting with audits/inspections. -Know who/how/where to gather information to answer technical questions.Responsible for application of GSK safety and environmental guidelines and act as a role model within the department. Ensure all job responsibilities are in compliance with applicable regulations, current operating procedures and industry practice. Identify and help mitigate EHS and safety risks. - Work with supervisor to mitigate safety concerns and provide guidance for teammates related to safety topics. - Hazardous waste training depending on specific requirements of the VS department.Ensure all activities are executed following quality and regulatory standards. - Supports cross-functional communication and the GSK quality mindset by proactively identifying and reporting compliance issues to area supervisor or QA. - Work with supervisor and QA to mitigate identified issues. - Adhere to all GSK QMS policies and procedures applicable to functional area. - Lead and facilitate the inspection readiness of the department.Participate in and support continuous improvement, and LEAN initiatives. - Recognize technical issues and relay to supervisor.Represent GSK with the highest level of integrity and professionalism. - Ability to maintain confidentiality of sensitive information. - Adhere to GSK policies and procedures and support management decisions and goals in a professional manner. - Show awareness of changing schedules, request and priorities put forth by management. - Hold self and teammates to applicable safety and quality standards. - Support cross-functional communication both within and external to the department. - Meet agreed timelines for task and escalate timeline adherence concerns to supervisor.Support production planning to achieve VS objectives, including delivery to yearly manufacturing plan.The following GSK Individual Expectations are key behavioral characteristics for this job role: Set direction & inspire, Work across boundaries, Release energy, Develop capability & talent, Drive performance, and Live our values. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: High School Diploma or equivalent Good oral and written communication skills. - Ability to communicate effectively and project a professional image when giving/taking information in person, in writing, or over the phone. - Understanding of Microsoft Office (MS Word, MS Excel, MS Outlook. -Understanding of weights and volume measures as well as a general knowledge of bio burden control techniques. Preferred Qualifications: If you have the following characteristics, it would be a plus: Bachelor's degree in technical/scientific field.Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem solving skills.Strong understanding of cGMP and quality systems including the ability to guide others in correct cGMP principles.Strong understanding of Quality systems to include deviation and CAPA systems.Exhibit leadership capabilities (e.g. influence, enable and drive change, and continuous improvement. Other Job-Related Skills/Background Bachelor's degree in technical field and 3 years of cGMP experienceORHigh school diploma or equivalent and 7 years GMP experience in the area of focus.Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem-solving skills.Strong understanding of cGMP and quality systems including the ability to guide others in correct cGMP principles.Strong understanding of Quality systems to include Deviation and CAPA systems.Exhibit leadership capabilities (e.g. influence, enable and drive change, and continuous improvement.Perform manufacturing/cleaning/sampling/processing steps in coordination with other manufacturing/QA/QC personnelHandling of hazardous waste from production activities to satellite storage areas. - Annual training on area-specific hazardous waste handling as required. - This training satisfies annual RCRA training requirement for large quantity generators and is part of the site's RCRA compliance program.Maintain and review training forms and filesParticipate in RCA for EHS incident and deviationsResponsible for writing and driving closure of deviations.Participate in presenting and maintaining site in a state of inspection readinessResponsible for participation/writing/closure of CAPA tasks both safety and quality relatedPerform duties as per written procedures and maintain strict adherence to those proceduresAsk for assistance and do not perform duties without appropriate trainingAttend all mandatory training and take a positive approach to complianceWork both independently and in a team environmentAdapt to changing schedules, priorities, and requests from supervisorUnderstand and adhere to cGMP requirementsIndependently operate production equipment per appropriate proceduresProficient in all aspects of team functions and employ bio burden control techniquesIdentify and assist in mitigation of safety issuesLead investigations both EHS and Quality relatedLead in risk assessments and L1 audits both EHS and Quality relatedWrite and revise procedures/protocolsDrive CAPA closureIdentify and implement process improvementsMaintain MBRs, logbooks, Room History Record, and other VS paperworkMaintain cGMP compliance in areas of responsibility and participates in internal and external auditsProvide technical expertise in equipmentCoordinate scheduling of equipment processing, maintenance, and calibration activitiesAssist VS Compliance team with area specific change controlWork with TS and others to trouble shoot equipment issuesParticipate in preparation and maintaining areas of responsibility in a state of inspection readinessMaintain an in-depth working knowledge of the area of responsibility and be able to transfer that knowledge to other team membersAct as the primary contact person for audits and inspections and act as designee for audit responses.Other duties as assigned by supervisor 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: v - Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.v - Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.v - Continuously looking for opportunities to learn, build skills and share learning.v - Sustaining energy and well-beingv - Building strong relationships and collaboration, honest and open conversations.v - Budgeting and cost-consciousnessIf 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/ AgenciesGSK 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.

Keywords: GSK, Coeur d'Alene , Value Stream Manufacturing Technical Expert - Purification, IT / Software / Systems , Hamilton, Idaho

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