Lean Manufacturing Specialist jobs in Boulder, CO

Lean Manufacturing Specialist assists with the implementation of Lean Manufacturing goals and strategies for improving the operations and processes within the organization. Evaluates all continuous improvement activities and implements plans to optimize performance and processes. Being a Lean Manufacturing Specialist employs Lean methodologies and tools in order to accomplish business objectives. Typically requires a bachelor's degree. Additionally, Lean Manufacturing Specialist also requires training and Lean certification through an accredited organization. Typically reports to a manager or head of a unit/department. To be a Lean Manufacturing Specialist typically requires 2 to 4 years of related experience. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work. (Copyright 2024 Salary.com)

Recently Added Lean Manufacturing Specialist jobs

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Manufacturing Investigations Specialist, Senior
  • AGC Biologics, Inc.
  • Boulder, CO FULL_TIME
  • Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. JOB SUMMARY This position is primarily responsible for management and completion of site investigations. This position is an individual contributor role that works cross-functionally to collect information used to assess impact, identify root cause, and mitigate recurrence through CAPAs. This position requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent. The successful candidate is able to work under the appropriate amount of direction based on level and possesses the ability to work on complex problems by analyzing procedures and data to create solutions. ESSENTIAL DUTIES AND RESPONSIBILITIES Owns, leads, authors, and drives site investigations to closure. Participates in or leads deviation related meetings, including: Cross-functional Triage meetings to gather facts/data upon event discovery Investigation planning meetings to aligning internal review team and area subject matter experts on an agreed upon investigational path forward Deviation and CAPA Review Board meetings to update leadership on current status of investigations Specialist may lead triage meetings and Deviation Review Board. Identifies Root Cause by utilizing common and advanced root cause analysis tools such as Control Charts, Fishbone Diagrams, 6Ms and 5 Whys. Authors Minor, Major and Critical investigation reports by utilizing robust technical writing skills to communicate moderate to complex technical issues. Serves as liaison between multiple teams including Manufacturing, MSAT, Engineering, Quality Control, Supply Chain and Quality Assurance to conduct and complete thorough deviation investigations. Ensures appropriate CAPAs are defined to address the identified root cause, and suitable Effectiveness Checks are put into place to proactively ensure the effectiveness of the CAPA. Monitors assigned deviations to ensure on time closure. Maintains SOPs and other GMP documents as needed to support the program. Participates in the Quality Risk Management program when requested. May support regulatory inspections as a Subject Matter Expert (SME) for Deviations. Acts as a mentor to peers for Root Cause analysis and Investigation writing. This position is a delegate for other Investigation Specialists. Specialist may be a delegate for the Manager, Investigations. KNOWLEDGE, SKILLS, AND ABILITIES To perform this job successfully, an individual should be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Strong knowledge of cGMP regulations and the ability to apply them to commercial manufacturing. Knowledge and understanding of Root Cause Analysis processes in a regulated environment. Skill in effective verbal and written communications. Ability to respond quickly to complex inquiries from customers, co-workers, and supervisors regarding deviation details. Demonstrated conflict resolution skills in a cross-functional setting with the ability to keep objectives on track. Proven technical writing skills within a cGMP manufacturing environment are required. Formal Technical Writing certification is strongly preferred. Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications, including MS Word, MS Excel and Teams (required), and with eQMS applications such as TrackWise (preferred). Demonstrated ability to work collaboratively to accomplish deadlines and objectives. Demonstrated ability to work in a fast-paced environment, with the ability to manage multiple projects and objectives for on-time event closure. Ability to be proactive, detail-oriented, and adapt to changing priorities. Biotech industry experience strongly preferred EDUCATION and/or EXPERIENCE BS in scientific discipline such as Bioprocess Engineering, Biochemistry, Chemistry, Biology or related discipline Experience with quality management system (MasterControl, TrackWise, etc.) software preferred Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) preferred Years of Experience Requirements Senior Specialist: Minimum 8 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or cGMP environment preferred Equivalent education and experience may substitute for stated requirements Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
  • 7 Days Ago
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Manufacturing Specialist I/II - 1st shift
  • Emerson
  • Boulder, CO OTHER
  • If you are a Manufacturing Specialist looking for an opportunity to grow, Emerson has an exciting opportunity located in Boulder, CO. As a manufacturing specialist you will be responsible for assembli...
  • 1 Month Ago
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Manufacturing Specialist I/II - weekend shift
  • Emerson Career Site
  • Boulder, CO FULL_TIME
  • If you are a Manufacturing Specialist looking for an opportunity to grow, Emerson has an exciting opportunity located in Boulder, CO. As a manufacturing specialist you will be responsible for assembli...
  • 1 Month Ago
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Manufacturing Technician
  • McKesson
  • Longmont, CO FULL_TIME
  • Job Descriptionob Description: This role is responsible for constructing, assembling, wiring, and plumbing electro-mechanical assemblies and automation equipment aimed at pharmaceutical distribution. ...
  • 19 Days Ago
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Manufacturing technician
  • Masco Corporation
  • Longmont, CO FULL_TIME
  • POSITION SUMMARY : The role is responsible for executing work activities to build, troubleshoot, qualify and maintain vacuum coating equipment and associated components. ESSENTIAL FUNCTIONS and RESPON...
  • Just Posted
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Manufacturing Technician
  • KBI Biopharma
  • Boulder, CO FULL_TIME
  • Position SummaryThis position operates on a 2-2-3 day shift schedule. The Manufacturing Technician position is designed as an introduction to the industry of cGMP manufacturing. This position performs...
  • 4 Days Ago
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0 Lean Manufacturing Specialist jobs found in Boulder, CO area

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Continuous Improvement Specialist
  • Safilo USA
  • Aurora, CO
  • Job Description Job Description The Company It is an exciting time at Safilo’s fast-growing state-of-the-art North Ameri...
  • 4/23/2024 12:00:00 AM
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Microbiology Laboratory Associate
  • GT Molecular
  • Fort Collins, CO
  • Do you want to work in a fast-paced, energizing laboratory with an interdisciplinary team of molecular biologists, infec...
  • 4/23/2024 12:00:00 AM
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System Engineer IT u2013 Manufacturing
  • CIBER
  • Denver, CO
  • HTC Global Services wants you. Come build new things with us and advance your career. At HTC Global you'll collaborate w...
  • 4/22/2024 12:00:00 AM
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INVENTORY SPECIALIST
  • The Geo Group Inc.
  • Boulder, CO
  • Benefits Information:Full-time employees will enjoy a competitive benefits package with options for you and your family ...
  • 4/22/2024 12:00:00 AM
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Safety Specialist
  • Carlisle Construction Materials
  • Mead, CO
  • The Regional Safety Specialist, East manages safety programs, compliance requirements based on OSHA and Carlisle safety ...
  • 4/22/2024 12:00:00 AM
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Manufacturing Engineer
  • Creation Technologies LP
  • Denver, CO
  • It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and ...
  • 4/21/2024 12:00:00 AM
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Conventional Machinist (Position located at Pueblo, CO)
  • Gulfco Manufacturing
  • Boulder, CO
  • Job Description Job Description Job Title: Conventional Machinist Department: Machine Shop Reports To: Supervisor of Dep...
  • 4/21/2024 12:00:00 AM
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Conventional Machinist (Position located at Pueblo, CO)
  • Gulfco Manufacturing
  • Denver, CO
  • Job Description Job Description Job Title: Conventional Machinist Department: Machine Shop Reports To: Supervisor of Dep...
  • 4/21/2024 12:00:00 AM
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About Boulder, Colorado

Boulder (/ˈboʊldər/) is the home rule municipality that is the county seat and the most populous municipality of Boulder County, Colorado, United States. It is the state's 11th most populous municipality; Boulder is located at the base of the foothills of the Rocky Mountains at an elevation of 5,430 feet (1,655 m) above sea level. The city is 25 miles (40 km) northwest of Denver. The population of the City of Boulder was 97,385 people at the 2010 U.S. Census, while the population of the Boulder, CO Metropolitan Statistical Area was 294,567. Boulder is known for its association with American fr...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Lean Manufacturing Specialist jobs
$85,387 to $109,703
Boulder, Colorado area prices
were up 2.3% from a year ago
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What does a Lean Manufacturing Specialist do?

Lean Manufacturing Specialist in Durham, NC
Prepare operational budgets to fund Lean annual activities and estimate productivity gains.
December 23, 2019
Lean Manufacturing Specialist in Fayetteville, NC
New York ranks number 1 out of 50 states nationwide for Lean Manufacturing Specialist salaries.
December 19, 2019
Lean Manufacturing Specialist in New Britain, CT
Support early integration of Lean principles in product design & process development for New Product Introductions.
December 17, 2019