Quality Assurance Specialist jobs in Lansing, MI
Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Specialist jobs
Senior Quality Assurance Specialist / Engineer
- Niowave Inc.
-
Lansing, MI
FULL_TIME
-
Senior Quality Assurance Specialist / EngineerWho we are…We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.Why patients need you…Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to our partners and patients. Our science and risk-based compliant quality culture is innovative and partner oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.Who you are…You have a precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent, efficient, diligent and technologically savvy. You also embrace change to keep pace with emerging information and shifting priorities, offering suggestions to improve process flows. You get great satisfaction from launching new products, improving compliance on existing products or procedures and rise to the occasion to take on miscellaneous projects. You easily transition between working independently to working with a team with excellent customer service as your internal guide.What you can expect to work on…You’ll provide instrumental support within the quality team and throughout the company to ensure timely project and compliance support.What you need to succeed…Excellent communication and interpersonal skills – you know how to develop & maintain strong relationships with all levels/teams of the organization. Understand how to integrate into a new team/organization – you appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand your own communication and learning styles, assess other styles, and are able to find the right path to connect the two. Exceptional technology skills – you find working with any software very comfortable and you easily adapt to new products.What You Will Achieve…The Senior Quality Assurance Specialist (Engineer) ensures compliant manufacturing procedures, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is part of a strong and growing team launching first of its kind products to accelerate the fight against cancer.Essential functions
- Utilize advanced quality tools to drive improvements, encompassing process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
- Monitor manufacturing processes and products, for adherence to both company and regulatory standards, and actively participate in quality improvement initiatives and projects.
- Support quality reviews and audits (internal and external) by evaluating data, preparing reports to verify regulatory compliance, identifying deviations and recommending opportunities for improvement.
- Lead and support validation of test methods, processes, and equipment by training quality and operations personnel.
- Act as a customer liaison, managing customer quality complaints.
- Lead and manage NPI quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
- Provide support for IND/DMF/IMPD submissions, product registrations, facility registrations, and IND submissions to the FDA and customers as required.
- Lead and support development of essential Quality System components, including complaint analysis, risk analysis, failure mode and effects analysis, NCMR, CAPA, complaints, and process/equipment/software verification/validation.
- Lead and support change requests by working closely with production to document and standardize process parameters.
- Lead and support pre- and post-production reviews, providing valuable quality and regulatory insights.
- Lead or guide teams through NCMR, complaints, and CAPA.
- Collaborate with cross-functional teams to solve production and quality challenges.
- Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
- Monitor internal and external quality metrics and proactively resolve issues related to product characteristics, features, and associated documentation.
- Lead and develop team members, nurturing a positive business culture that aligns with our values and leadership competencies.
- Function as an independent Reviewer for team and coworkers throughout the team as needed to support continued training, guidance and ensure quality and regulatory.
Competencies- Highly accountable, visionary leader with excellent management aptitude both in theory and application.
- Excellent interpersonal, written, and oral communication skills.
- Strong mechanical aptitude.
- Able to prioritize and execute tasks in a high-pressure environment.
- Expertly performs in a team-oriented, collaborative environment.
- Highly values integrity, professionalism, and confidentiality.
- Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
- Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
- Understands their own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two.
Education and experience- Minimum of five (5) years’ experience in an FDA regulated industry, preferably in pharmaceuticals. Three (3) or more years in a Quality role, preferably Quality Assurance.
- Bachelor’s degree in Sciences or Engineering (e.g., Chemical, Mechanical, Manufacturing, Industrial).
- Engineering experience in both the Research/Development and Production environments.
- Experience applying lean manufacturing principles and practices.
Work EnvironmentThis job operates in a professional office environment. This role routinely uses standard office equipment.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 pounds.Position Type/Expected Hours of WorkThis is a full-time position. Days of work are typically Monday through Friday, 8 a.m. to 5 p.m. Production support on off shifts are weekends will be required as needed to ensure quality support is present.TravelTravel is primarily local during the business day between the company’s two locations.
- 1 Month Ago
Manager, Quality Assurance
- Delta Dental of Michigan
-
Okemos, MI
FULL_TIME
- This is a hybrid position, both in-office and remote. Delta Dental of Michigan, Ohio, and Indiana is a leader in dental benefits, plus so much more. We improve oral health through benefit plans, advoc...
- 2 Days Ago
Quality Assurance Analyst
- Michigan Milk Producers Assoc
-
Ovid, MI
FULL_TIME
- Quality Assurance AnalystThe Michigan Milk Producers Association- MMPA is currently seeking a highly motivated individual for our fast-paced Quality Department, as a Quality Assurance Analyst in our O...
- 7 Days Ago
Transportation Engineer Licensed Specialist 13 (Road Scoping & Quality Assurance) University Region
- State of Michigan
-
Jackson, MI
FULL_TIME
- POSTING MAY CLOSE AT ANY TIME ONCE THE POSTIION HAS BEEN FILLED.As the Road Scoping and Quality Assurance (QA) Engineer for the University Region, this position will serve as the technical expert and ...
- 30 Days Ago
MDOT - Senior Quality Assurance Analyst (587634)
- Key Business Solutions, Inc.
-
LANSING, MI
FULL_TIME
- MDOT - Senior Quality Assurance Analyst (587634) 12 Months Lansing MI 48909 F2F Short Description: This position will serve as a senior level quality assurance analyst with the Department of Technolog...
- 18 Days Ago
Quality Assurance Tester/Developer (ITPA11) supporting MSP
- State of Michigan
-
Dimondale, MI
FULL_TIME
- The Department of Technology, Management and Budget (DTMB) supports the business operations of state agencies through a variety of services, including building management and maintenance, information ...
- 1 Day Ago
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0 Quality Assurance Specialist jobs found in Lansing, MI area
Electrical Project Manager
- Colliers Engineering & Design
-
Lansing, MI
- Overview: Colliers Engineering & Design is currently seeking Project Managers to join our Buildings/Electrical team in o...
- 4/24/2024 12:00:00 AM
Validation Project Manager
- Neogen Corporation
-
Lansing, MI
- Come Be Part of a Mission that Matters! Neogen is looking to hire a Validation Project Manager who will be responsible f...
- 4/23/2024 12:00:00 AM
Manager, Quality Assurance
- Renaissance Health Services Corporation
-
Okemos, MI
- Requirements Position requires a bachelor's degree in computer science, information technology or a related field and se...
- 4/22/2024 12:00:00 AM
Quality Control Plant Inspector - Howell
- Medline Industries
-
Howell, MI
- JOB SUMMARY: 1st Shift 6am - 2:30pm Responsible for the inspection of raw materials and finished goods (including medica...
- 4/22/2024 12:00:00 AM
Associate Director, GMP Quality Control
- Sumitomo Pharma
-
Lansing, MI
- Associate Director, GMP Quality Control Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientif...
- 4/22/2024 12:00:00 AM
Production and Quality Supervisor / Group Leader
- Iconma LLC
-
Lansing, MI
- One of our large Automotive Clients based in Lansing, MI is looking for a few Production and/or Quality Supervisors to m...
- 4/22/2024 12:00:00 AM
Production and Quality Supervisor / Group Leader
- ICONMA, LLC
-
Lansing, MI
- One of our large Automotive Clients based in Lansing, MI is looking for a few Production and/or Quality Supervisors to m...
- 4/22/2024 12:00:00 AM
Quality Engineer
- Venteon
-
Lansing, MI
- This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assuranc...
- 4/22/2024 12:00:00 AM
About Lansing, Michigan
Lansing /ˈlænsɪŋ/ is the capital of the U.S. state of Michigan. It is mostly in Ingham County, although portions of the city extend west into Eaton County and north into Clinton County. The 2010 Census placed the city's population at 114,297, making it the fifth largest city in Michigan. The population of its Metropolitan Statistical Area (MSA) was 464,036, while the even larger Combined Statistical Area (CSA) population, which includes Shiawassee County, was 534,684. It was named the new state capital of Michigan in 1847, ten years after Michigan became a state.
The Lansing metropolitan area,...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$59,521 to $75,356
Lansing, Michigan area prices
were up 1.3% from a year ago
were up 1.3% from a year ago
What does a Quality Assurance Specialist do?
Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020