Lean Manufacturing Specialist jobs in Chapel Hill, NC

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)

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MQA Specialist
  • Indivior Manufacturing LLC (Salaried)
  • Raleigh, NC FULL_TIME
  • TITLE: MQA Specialist Title: MQA Specialist Reports To: MQA Manager Location: Raleigh, NC Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. POSITION SUMMARY: The MQA Specialist is a critical member of the Quality Assurance team. Reporting to the Manager of Manufacturing Quality Assurance (MQA), this individual plays a key role in ensuring the delivery of quality products. The MQA Specialist will provide direct support on the floor for manufacturing activities at the Raleigh site as well as the release of raw materials and components. They will ensure compliance to SOPs, approved Batch Records and cGMPs They must have extensive knowledge of the manufacturing process where they will routinely evaluate and resolve process issues in cooperation with Production and support personnel to ensure product quality. Works closely with Production personnel to complete on-the-floor, in-process batch record review, resolve all batch related issues, and ensure proper good documentation practices. Recommend corrective actions or process improvements that will eliminate the potential for manufacturing deviations. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decisions regarding quality related concerns or issues. Works closely with Compliance Quality Management, as needed. Demonstrate a proficient knowledge of the manufacturing process and site procedures. Addresses daily quality concerns and questions related to operating and environmental issues. Clearly communicate complex issues to Management personnel. Evaluates the manufacturing areas for recommended improvements that will eliminate the potential for deviations. Work closely with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling. Completes gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices. Identify deviations and ensure the deviations are initiated by the appropriate personnel. Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities. Assists in analysis of inspection rejects; assists in investigation of causes and implementation of corrective actions. Responsible for data review for the disposition of raw materials, components and GxP supplies. Performs AQL checks on product when necessary and maintain AQL qualification status. Perform and document assessments of aseptic behaviour inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Incumbent must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation. Inspect the physical conditions of the aseptic manufacturing area on a routine basis. Provide good aseptic technique and gown re-training to individuals, as required per the RPN program. Provide backup support to the Environmental Monitor group as needed and as approved by management. Perform additional duties and responsibilities as assigned. Ensure processes and products comply with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. MINIMUM QUALIFICATIONS: Bachelor of Science degree in Life or Physical Sciences with one (1) to five (5) years equivalent education/professional experience. Pharmaceutical industry experience is required, sterile quality/manufacture experience preferred Must have a strong work ethic and be highly motivated to resolve issues. Quality or Pharmaceutical certifications a plus. Visual acuity to detect defective vials and syringes during the evaluation of defects and AQL checks. Oral and written communication skills required between departments, as well as levels of management. Strong analytical skills with the ability to think strategically. Computer experience required; must be proficient in Microsoft Word and Excel functions. PHYSICAL REQUIREMENTS OF THE ROLE: Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes 3 weeks’ vacation plus floating holidays and sick leave 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health and Dependent Care Flex Spending options Adoption assistance Tuition reimbursement Leverage Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage Gym, fitness facility and cell phone discounts Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees. GUIDING PRINCIPLES: Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient. The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making. Indivior Guiding Principles: Focus on Patient Needs to Drive Decisions Believe that People’s Actions are Well Intended Seek the Wisdom of the Team Care Enough to Coach See it, Own it, Make it Happen Demonstrate Honesty and Integrity at All Times For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.
  • 7 Days Ago

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Manufacturing Specialist
  • Beam Therapeutics
  • Durham, NC FULL_TIME
  • Position Overview: The Manufacturing Specialist will support cGMP activities at the Durham North Carolina Site. The Manufacturing Specialist will have responsibility to assure initiatives related to p...
  • 19 Days Ago

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Manufacturing Specialist
  • Alcami Corporation
  • Durham, NC FULL_TIME
  • Job Summary: The Manufacturing Specialist supports cGMP manufacturing of various drug products and troubleshoots unexpected manufacturing events. This includes preparing, conducting, and evaluating co...
  • 22 Days Ago

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Specialist, Manufacturing Automation
  • OneTen
  • Wilson, NC FULL_TIME
  • Job DescriptionThis individual will provide first line automation support for assigned line(s)/system(s) and/or engineering projects. Work with plant maintenance, operations and process improvement te...
  • 22 Days Ago

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Manufacturing Specialist Intern
  • KBI Biopharma
  • Durham, NC INTERN
  • Position SummaryAssist with drafting, and revision of manufacturing batch records, procedures, and supporting records.Support new equipment enrollment qualification activities.Assist SMEs with laborat...
  • 24 Days Ago

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BOM Manufacturing Specialist
  • Studio TK LLC
  • Clayton, NC FULL_TIME
  • What we are looking for Studio TK is looking for a Data Specialist / BOM (Bill of Material) Specialist to join our systems engineering team. Reporting directly to the ERP Engineering Manager, this pos...
  • 12 Days Ago

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0 Lean Manufacturing Specialist jobs found in Chapel Hill, NC area

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Senior Operational Specialist
  • Merck
  • Durham, NC
  • Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing p...
  • 3/28/2024 12:00:00 AM

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Arby's Shift Manager
  • KBP Inspired
  • Carrboro, NC
  • Ready to take charge of your career? Our KBP Inspire Franchise Location is in search of driven Shift Manager to join our...
  • 3/28/2024 12:00:00 AM

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Food Prep Worker: UNC Lenoir Dining hall
  • ARAMARK Refreshment Services, Inc.
  • Chapel Hill, NC
  • Job Description The Food Prep Worker prepares, and portions food items and performs various duties in accordance with pr...
  • 3/28/2024 12:00:00 AM

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Quality & Organizational Excellence Leader Emergency Services
  • UNC Health Care Systems
  • Chapel Hill, NC
  • Description Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the...
  • 3/28/2024 12:00:00 AM

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Aesthetic Injector - H/K/B Cosmetic Surgery
  • HKB COSMETIC SURGERY
  • Chapel Hill, NC
  • Job Description Job Description H/K/B Cosmetic Surgery has an exciting opportunity for a full-time Aesthetic Injector to...
  • 3/28/2024 12:00:00 AM

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Taco Bell - Shift Manager - Urgently Hiring
  • Taco Bell
  • Chapel Hill, NC
  • Shift Manager Taco Bell is looking for people who love serving customers, have experience in the restaurant industry and...
  • 3/27/2024 12:00:00 AM

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Industry Transformation Advisor (Smart Manufacturing)
  • Avanade Inc.
  • Durham, NC
  • Industry Transformation Advisor (Smart Manufacturing) Introduction: Avanades Integrated Go-To-Market (IGTM) function bri...
  • 3/26/2024 12:00:00 AM

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Industry Transformation Advisor (Smart Manufacturing)
  • Avanade Inc.
  • Cary, NC
  • Industry Transformation Advisor (Smart Manufacturing) Introduction: Avanades Integrated Go-To-Market (IGTM) function bri...
  • 3/26/2024 12:00:00 AM

Chapel Hill is a town in Orange, Chatham, and Durham counties in the U.S. state of North Carolina. Its population was 57,233 in the 2010 census, making Chapel Hill the 15th-largest city in the state. Chapel Hill, Durham, and the state capital, Raleigh, make up the corners of the Research Triangle (officially the Raleigh–Durham–Chapel Hill combined statistical area), with a total population of 1,998,808. The town was founded in 1793 and is centered on Franklin Street, covering 21.3 square miles (55 km2). It contains several districts and buildings listed on the National Register of Historic Pla...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Lean Manufacturing Specialist jobs
$78,125 to $100,363
Chapel Hill, North Carolina area prices
were up 1.5% from a year ago

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