Value Stream Manufacturing Lead
- Missoula, MT
Site Name: USA - Montana - Hamilton
Posted Date: Jan 6 2021
As a Value Stream Manufacturing Lead, 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. You will also train and mentor less experienced staff, work with minimal supervision and coordinate complex tasks between departments.You will oversee and coordinate equipment related task and issues and demonstrate ability to cross train in multiple disciplines across the Value Stream and participate in cross functional teams. You will also take initiative, provide 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 and fills in when supervisor is out, and when necessary be willing and able to make decisions with regard to day to day operations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- 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. Drive and champion LEAN behaviors within the team.
- 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. Assist in and allocate time for other team members to complete assigned tasks.
- Support production planning to achieve VS objectives, including delivery to yearly manufacturing plan. Assist supervisor in setting, monitoring, and achieving area objectives, metrics and targets.
- The following GSK values and expectations are key behavioral characteristics for this role: Patient Focus, Transparency, Respect, and Integrity, Courage, Accountability, Development, and Teamwork
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree and 3 years of cGMP/healthcare/lab related experience.
- Good verbal and written communication skills.
- Experience with communicating 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.
- 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.
- Working understanding of SAP requirements related to area specific functions and ability to direct team members in the correct use of SAP.
- Perform manufacturing/cleaning/sampling/processing steps in coordination with other manufacturing/QA/QC personnel.
- Identify and assist in mitigation of safety issues
- Lead investigations both EHS and Quality related
- Lead in risk assessments and L1 audits both EHS and Quality related
- Write and revise procedures/protocols
- Drive CAPA closure
- Identify and implement process improvements
- Maintain MBRs, logbooks, Room History Record, and other VS paperwork
- Maintain cGMP compliance in areas of responsibility and participates in internal and external audits
- Provide technical expertise in equipment
- Coordinate scheduling of equipment processing, maintenance, and calibration activities
- Assist VS Compliance team with area specific change control
- Work with TS and others to trouble shoot equipment issues
- Participate in preparation and maintaining areas of responsibility in a state of inspection readiness
- Act as the point of contact when supervisor is not available
- Be able and willing to make decisions when supervisor is not available
- Participate in the hiring process when necessary.
- Other duties as assigned by supervisor
If you have the following characteristics, it would be a plus:
- Bachelor's degree in the Technical/Science field
- Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem-solving skills
- Exhibit leadership capabilities (e.g. influence, enable and drive change, and continuous improvement.
- 3 years of cGMP/healthcare/lab related experience.
- Potential handling 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 files
- Participate in RCA for EHS incident and deviations
- Participate in presenting and maintaining site in a state of inspection readiness
- Potentially responsible for participation/writing/closure of CAPA tasks both safety and quality related
- Perform duties as per written procedures and maintain strict adherence to those procedures
- Ask for assistance and do not perform duties without appropriate training
- Attend all mandatory training and take a positive approach to compliance
- Work both independently and in a team environment
- Adapt to changing schedules, priorities, and requests from supervisor
- Understand and adhere to cGMP requirements
- Independently operate production equipment per appropriate procedures
- Lead in all aspects of team functions and employ bioburden control techniques
Our values and expectationsare 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.
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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.
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