Lean Manufacturing Specialist, Sr. jobs in Greenville, NC
Lean Manufacturing Specialist, Sr. implements Lean Manufacturing goals and strategies for improving the operations and processes within the organization. Evaluates all continuous improvement activities and develops plans to optimize performance and processes. Being a Lean Manufacturing Specialist, Sr. employs Lean methodologies and tools in order to accomplish business objectives. Typically requires a bachelor's degree. Additionally, Lean Manufacturing Specialist, Sr. 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, Sr. typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Recently Added Lean Manufacturing Specialist, Sr. jobs
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.
- 2 Months Ago
Sr Director, Manufacturing Controlling, Americas
- bioMerieux Inc.
-
Durham, NC
FULL_TIME
- Description Position Summary:Reporting to the Sr. VP Global Manufacturing, Supply Chain, and Quality and functionally to the Sr VP Manufacturing Americas, you are the finance business partner of manuf...
- 11 Days Ago
Sr. Project Engineer I, Technical Manufacturing Solutions
- Precision for Medicine
-
Raleigh, NC
FULL_TIME
- Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As...
- Just Posted
Sr. Project Engineer I, Technical Manufacturing Solutions
- Precision Medicine Group
-
Raleigh, NC
FULL_TIME
- Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As...
- Just Posted
Sr. Project Engineer I, Technical Manufacturing Solutions
- Project Farma
-
Raleigh, NC
FULL_TIME
- Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As...
- Just Posted
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...
- 7 Days Ago
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0 Lean Manufacturing Specialist, Sr. jobs found in Greenville, NC area
Sr Manufacturing Engineer (Onsite)
- Raytheon Technologies
-
Wilson, NC
- Date Posted: 2024-04-19 Country: United States of America Location: HSK02: Kidde Aerospace 4200 Airport Drive,NW, Wilson...
- 5/9/2024 12:00:00 AM
Technical Writer
- Catalent, Inc.
-
Greenville, NC
- The Technical Writer will Develop, create and maintain documentation, particularly protocols and Master Batch Records in...
- 5/8/2024 12:00:00 AM
Continuous Improvement Manager 3
- Perdue Farms
-
Lewiston, NC
- We are actively recruiting for a Continuous Improvement Manager to be based at our Lewiston facility. This individual dr...
- 5/8/2024 12:00:00 AM
Production Supervisor
- Refresco
-
Wilson, NC
- Make a Difference in YOUR Career! Our vision is both simple and ambitious: to put our drinks on every table. We are the ...
- 5/7/2024 12:00:00 AM
Commodity Buyer/ Packaging
- MANN+HUMMEL
-
Washington, NC
- As worldwide experts in filtration, MANN+HUMMEL develop solutions for vehicles, industrial applications, clean air insid...
- 5/5/2024 12:00:00 AM
Senior Industrial Engineer (Onsite)
- Raytheon Technologies
-
Wilson, NC
- Date Posted: 2024-04-30 Country: United States of America Location: HSK02: Kidde Aerospace 4200 Airport Drive,NW, Wilson...
- 5/5/2024 12:00:00 AM
About Greenville, North Carolina
Greenville is the county seat and the most populous city in Pitt County, North Carolina, United States; the principal city of the Greenville metropolitan area; and the 11th-most populous city in the U.S. state of North Carolina. Greenville is the health, entertainment, and educational hub of North Carolina's Tidewater and Coastal Plain. The city's official population as of the 2017 United States census estimate is 92,156 residents while the Greenville Metropolitan Area includes 179,042 people, making Greenville one of the densest municipalities in the state. In January 2008 and January 2010, G...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Lean Manufacturing Specialist, Sr. jobs
$97,845 to $128,872
Greenville, North Carolina area prices
were up 1.5% from a year ago
were up 1.5% from a year ago