Quality Control Manager

49505 Grand Rapids, Michigan Transcendia, Inc.

Posted 7 days ago

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Job Description

Summary Plans, coordinates, and directs quality control program designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinate supervisors.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.

Formulates and maintains quality control objectives complementary to corporate policies and goals.

Creates and implements inspection criteria and procedures.

Interprets quality control philosophy to key personnel in organization.

Coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.

Provides inspection activity for product throughout production cycle.

Applies total quality management tools and approaches to analytical and reporting processes within each department.

Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.

Works with vendors to insure quality of all purchased parts for company use.

Creates and directs environmental test functions.

Plays active role on quality management teams within organization.

Designs and implements quality control training programs to key personnel in conjunction with managers.

Investigates and adjusts customer complaints regarding quality.

Supervisory Responsibilities

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies :

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

Customer Service

Interpersonal Skills

Oral Communication

Computer Skills

Education and/or Experience

Bachelor's degree (B. A.) or two to three years related experience and/or training; or equivalent combination of education and experience.
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Senior Quality Control Inspector

49503 Grand Rapids, Michigan $28 Hourly WhatJobs

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full-time
Our client, a leader in advanced manufacturing, is seeking a highly motivated and detail-oriented Senior Quality Control Inspector to join their remote operations team. This pivotal role is responsible for ensuring that all manufactured products meet stringent quality standards through comprehensive inspection and testing processes. The ideal candidate will possess a deep understanding of manufacturing workflows, quality assurance methodologies, and advanced measurement techniques. You will be instrumental in identifying defects, analyzing root causes, and collaborating with production teams to implement corrective actions. This is a fully remote position, offering the flexibility to work from anywhere within the US. You will utilize state-of-the-art remote monitoring tools and collaborate with cross-functional teams via video conferencing and project management software. Your responsibilities will include developing and implementing inspection plans, calibrating testing equipment, maintaining detailed inspection records, and preparing quality reports for management. You will also participate in continuous improvement initiatives, contributing to the enhancement of quality systems and product reliability. A strong background in statistical process control (SPC) and familiarity with ISO 9001 standards are highly desirable. This role requires exceptional analytical skills, problem-solving abilities, and a proactive approach to quality assurance. We are looking for an individual who can work independently, manage their time effectively, and maintain a high level of accuracy in a fast-paced environment. Experience with various inspection tools such as calipers, micrometers, and CMMs (Coordinate Measuring Machines) is essential. A commitment to upholding the highest standards of quality and contributing to the success of our client's products is paramount. If you are passionate about quality and thrive in a remote work setting, we encourage you to apply.
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Senior Quality Control Inspector

49501 Grand Rapids, Michigan $65000 Annually WhatJobs

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full-time
Our client, a leading manufacturing firm in Grand Rapids, Michigan , is seeking a meticulous and experienced Senior Quality Control Inspector to join their production team. This role is essential for ensuring that all manufactured products meet stringent quality standards and customer specifications. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of manufacturing processes and inspection techniques. You will be responsible for implementing and overseeing quality control procedures throughout the production cycle, from raw material inspection to final product verification.

Key responsibilities include conducting detailed inspections of incoming raw materials, in-process components, and finished goods using various measurement tools and equipment. You will be responsible for interpreting blueprints, technical drawings, and specifications to ensure product conformity. The Senior Quality Control Inspector will identify and document non-conforming products, initiate corrective actions, and track their resolution. Developing and implementing quality control plans and procedures, and ensuring adherence to these plans by production personnel, is crucial. You will also be involved in calibration and maintenance of inspection equipment. Collaboration with production, engineering, and purchasing departments to resolve quality issues and implement process improvements is essential. Conducting internal audits to assess compliance with quality management systems (e.g., ISO 9001) will also be a key responsibility. This role requires a strong understanding of statistical process control (SPC) and data analysis to identify trends and areas for improvement. The successful candidate will also provide training and guidance to junior quality control staff. This is an excellent opportunity to contribute to a reputable manufacturing company, ensuring the highest standards of product quality and customer satisfaction.

Qualifications:
  • High School Diploma or GED required; Associate's degree in a technical field or equivalent experience preferred.
  • Minimum of 5 years of experience in quality control inspection within a manufacturing environment.
  • Proficiency in using various inspection tools and equipment, including calipers, micrometers, gauges, and optical comparators.
  • Ability to read and interpret blueprints, technical drawings, and specifications.
  • Knowledge of quality management systems (e.g., ISO 9001) and statistical process control (SPC).
  • Strong analytical and problem-solving skills, with excellent attention to detail.
  • Good communication and teamwork skills.
  • Experience in the automotive or aerospace manufacturing sectors is a plus.
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Senior Quality Control Inspector - Manufacturing

49501 Grand Rapids, Michigan $70000 Annually WhatJobs

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full-time
Our client, a well-established manufacturing company, is seeking a highly detail-oriented and experienced Senior Quality Control Inspector to join their team in Grand Rapids, Michigan, US . This vital role ensures that all manufactured products meet stringent quality standards and specifications before they are released to customers. You will be responsible for performing comprehensive inspections and tests on raw materials, in-process components, and finished goods using various measuring instruments and quality control techniques. The Senior QC Inspector will also play a key role in identifying non-conforming products, documenting quality issues, and participating in corrective action investigations.

Key responsibilities include developing and implementing inspection plans, calibrating and maintaining inspection equipment, and interpreting engineering drawings and specifications. You will conduct audits of manufacturing processes to ensure compliance with quality management systems (e.g., ISO 9001). The Senior QC Inspector will also train and mentor junior inspectors, provide guidance on quality procedures, and contribute to continuous improvement initiatives within the quality department. Your input will be critical in identifying trends and implementing preventative measures to enhance overall product quality and reduce defects.

The ideal candidate will possess an Associate's degree in a technical field or equivalent experience, with a minimum of 6 years of experience in quality control inspection within a manufacturing environment. Proficiency with precision measuring tools (calipers, micrometers, gauges) and a strong understanding of statistical process control (SPC) are essential. Experience with reading and interpreting blueprints, schematics, and technical documentation is required. Knowledge of quality management systems and audit procedures is highly desirable. Excellent analytical, problem-solving, and documentation skills are critical. Strong attention to detail and the ability to work independently or as part of a team are necessary. This is an excellent opportunity for a seasoned QC professional to contribute to a reputable manufacturing organization.
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Senior Pharmaceutical Quality Control Analyst

49501 Grand Rapids, Michigan $80000 Annually WhatJobs

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full-time
A cutting-edge pharmaceutical company dedicated to developing innovative therapies is seeking a highly meticulous and experienced Senior Pharmaceutical Quality Control Analyst to join their state-of-the-art laboratory in Grand Rapids, Michigan, US . This critical role is responsible for ensuring the quality and compliance of pharmaceutical products throughout the manufacturing process. You will perform a variety of analytical tests on raw materials, in-process samples, and finished products using advanced laboratory equipment. The ideal candidate will possess a strong background in analytical chemistry, a thorough understanding of GMP (Good Manufacturing Practices), and extensive experience in pharmaceutical quality control. Responsibilities include developing and validating analytical methods, maintaining laboratory equipment, documenting all testing procedures and results accurately, and participating in regulatory audits. You will collaborate with R&D, manufacturing, and regulatory affairs teams to resolve quality issues and ensure product integrity. Proficiency in techniques such as HPLC, GC, UV-Vis spectroscopy, and other relevant analytical methods is essential. A Bachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field, along with significant experience in the pharmaceutical industry, is required. This is an exceptional opportunity to contribute to the development and release of life-saving medications and to advance your career within a leading pharmaceutical organization in Grand Rapids, Michigan, US .
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Quality Assurance Specialist

49507 Grand Rapids, Michigan Actalent

Posted 3 days ago

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Job Title: Quality Assurance AssociateJob Description
The Regulatory Affairs Specialist/Compliance Specialist/QA Specialist plays a crucial role in overseeing regulatory affairs activities for a contract development and manufacturing organization (CDMO). This position is integral to supporting regulatory needs for sterile injectable products, spanning from clinical through commercial phases. The Specialist will manage a wide array of projects, interacting with all internal departments, external clients, suppliers, contractors, and regulatory agencies. Please note, this role is not remote.
Responsibilities
+ Maintain current knowledge of all relevant regulations and monitor changes impacting product manufacturing.
+ Communicate regulatory requirements to stakeholders to ensure compliance.
+ Provide regulatory CMC support and review client submissions to align with supply agreements.
+ Submit and maintain letters of authorizations for client Type V Drug Master File submissions.
+ Manage FDA establishment registrations and product listings, including filing and obtaining new registrations.
+ Generate and maintain NDC codes for FDA approved commercial products for Cares Act Reporting.
+ Facilitate quality agreements with clients, ensuring alignment with regulatory requirements.
+ Submit annual GDUFA self-identifications to FDA.
+ Maintain and update the Type V Drug Master File, including amendments and annual reports.
+ Oversee the maintenance of Site Master Files for facilities.
+ Support business development due diligence evaluations and contribute to new-business selections.
+ Develop and maintain SOPs, work instructions, and related documentation for Regulatory Affairs.
+ Perform Regulatory Assessments for the holistic change control process.
+ Write, revise, and review departmental SOPs and associated documents.
+ Support agency, customer, and vendor audits as required.
Essential Skills
+ Bachelor's degree in Life Sciences or related field.
+ 5+ years of experience in a regulated pharmaceutical/medical device industry.
+ Hands-on experience in Regulatory Affairs with growing responsibilities.
+ Working knowledge of regulatory requirements (FDA/ICH regulations, GDUFA).
+ Familiarity with regulatory submissions for INDs, ANDAs, NDAs, and DMFs.
+ Knowledgeable in regulatory science and submission data requirements.
+ Understanding of cGMP, ICH, and USP regulations or guidelines.
+ Excellent technical writing skills.
+ Experience in preparing FDA correspondence.
Additional Skills & Qualifications
+ Experience with regulatory submissions and post-approval supplements.
+ Knowledge of sterile parenteral product development phases.
Work Environment
This position is based in an office environment.
Job Type & Location
This is a Contract position based out of Grand Rapids, Michigan.
Pay and Benefits
The pay range for this position is $40.00 - $52.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Grand Rapids,MI.
Application Deadline
This position is anticipated to close on Aug 27, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Senior Pharmaceutical Quality Assurance Specialist

49501 Grand Rapids, Michigan $85000 Annually WhatJobs

Posted today

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Job Description

full-time
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly qualified Senior Pharmaceutical Quality Assurance Specialist for their facility in Grand Rapids, Michigan, US . This role is instrumental in upholding the company's stringent quality standards and ensuring compliance with regulatory requirements throughout the drug development and manufacturing lifecycle. The ideal candidate will possess extensive knowledge of cGMP, regulatory affairs, and quality systems within the pharmaceutical sector. This position demands a meticulous approach, strong analytical capabilities, and a commitment to maintaining the highest levels of product integrity and patient safety.

Key Responsibilities:
  • Develop, implement, and maintain comprehensive quality assurance programs and systems in compliance with cGMP and relevant regulatory guidelines (e.g., FDA, EMA).
  • Conduct internal audits and inspections of manufacturing processes, documentation, and facilities to ensure adherence to quality standards.
  • Review and approve batch records, validation protocols, and deviation reports.
  • Manage and investigate deviations, out-of-specification (OOS) results, and customer complaints.
  • Participate in external audits by regulatory agencies and customers, acting as a key point of contact.
  • Develop and deliver training programs on quality assurance principles and cGMP requirements.
  • Prepare and review regulatory submission documentation.
  • Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to address quality issues and drive continuous improvement.
  • Maintain up-to-date knowledge of evolving regulatory landscapes and industry best practices.
  • Manage the CAPA (Corrective and Preventive Action) system, ensuring timely and effective implementation of actions.
  • Assess and qualify external suppliers and vendors.
  • Contribute to the development and improvement of quality policies and procedures.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
  • Minimum of 7 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of current Good Manufacturing Practices (cGMP), ICH guidelines, and regulatory requirements.
  • Proven experience with pharmaceutical manufacturing processes, validation, and documentation.
  • Strong analytical and problem-solving skills, with a keen attention to detail.
  • Excellent written and verbal communication skills, with the ability to present complex information clearly.
  • Experience with regulatory audits and inspections.
  • Ability to work effectively in a team-oriented, fast-paced environment.
  • Proficiency in quality management software and tools.
This is an exceptional opportunity to contribute to a groundbreaking pharmaceutical company and play a vital role in bringing life-changing therapies to patients worldwide.
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Senior Pharmaceutical Quality Assurance Specialist

49503 Grand Rapids, Michigan $98000 Annually WhatJobs

Posted 8 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to uphold the highest standards of quality and compliance in their operations in Grand Rapids, Michigan, US . This role is vital for ensuring that all pharmaceutical products meet rigorous regulatory requirements, industry standards, and internal quality specifications throughout their lifecycle. The ideal candidate will possess a comprehensive understanding of Good Manufacturing Practices (GMP), regulatory affairs, quality control testing, and documentation management within the pharmaceutical industry. You will be responsible for developing and implementing quality systems, conducting internal audits, reviewing batch records, and supporting regulatory inspections. Key responsibilities include:
  • Developing, implementing, and maintaining the company's Quality Management System (QMS).
  • Ensuring compliance with FDA regulations (e.g., 21 CFR Part 210/211), ICH guidelines, and other relevant regulatory requirements.
  • Reviewing and approving batch production and control records, ensuring completeness and accuracy.
  • Conducting internal audits of manufacturing processes, quality control, and documentation to identify areas of non-compliance.
  • Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
  • Participating in external regulatory inspections and audits by health authorities (e.g., FDA).
  • Developing and delivering quality assurance training to personnel.
  • Reviewing and approving validation protocols and reports for equipment, processes, and analytical methods.
  • Managing change control processes effectively.
  • Collaborating with all departments to foster a culture of quality and continuous improvement.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 5 years of experience in Quality Assurance or Quality Control within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of GMP, GDP, and relevant regulatory guidelines.
  • Experience with quality systems, deviation management, CAPA, and change control.
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and documentation practices.
  • Proficiency in Microsoft Office Suite and quality management software.
  • Strong communication and interpersonal skills.
This is a significant opportunity to contribute to the development and manufacturing of life-saving medications.
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Senior Pharmaceutical Quality Assurance Specialist

49503 Grand Rapids, Michigan $110000 Annually WhatJobs

Posted 13 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is looking for a highly motivated and experienced Senior Pharmaceutical Quality Assurance Specialist to join their team in **Grand Rapids, Michigan, US**. This pivotal role ensures that all manufactured pharmaceutical products meet rigorous quality standards and comply with regulatory requirements, including FDA, GMP, and other relevant authorities. Key responsibilities include developing, implementing, and maintaining quality management systems, conducting internal audits and supplier audits, reviewing batch records, investigating deviations and out-of-specification results, and managing corrective and preventive actions (CAPAs). You will also be involved in validating processes and equipment, managing change control procedures, and contributing to regulatory submissions. The ideal candidate possesses a strong understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. Excellent analytical, problem-solving, and decision-making skills are essential, along with meticulous attention to detail and strong documentation practices. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. A Master's degree or advanced training in Quality Assurance is highly preferred. A minimum of 5 years of experience in pharmaceutical quality assurance is necessary. This full-time position offers a competitive salary, excellent benefits, and significant opportunities for career growth within a respected organization at the forefront of pharmaceutical innovation. If you are dedicated to ensuring the highest standards of pharmaceutical quality and safety, we invite you to apply for this challenging role in **Grand Rapids, Michigan, US**.
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Manager Quality Assurance

49504 Grand Rapids, Michigan Perrigo Company Corporate

Posted today

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Job Description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

This position is responsible for leading quality engineering and quality control laboratory including the receiving quality inspection team in the development and maintenance of an effective QMS system. This requires improving quality systems within the scope of the role, providing oversight of internal quality metrics, and responding to customer quality inquiries. This individual will drive short term and long-term actions to achieve business goals, while deploying strategic and practical improvements to drive efficiency and accuracy.

Scope of the Role

* Direct oversight of Quality Control Laboratory personnel and Quality Engineering; including but not limited to training/re-training employees, documenting employee performance, participating in performance management cycles to provide written and verbal. feedback, and partnering with others to drive conflict resolution within organization.
* Develop personnel to ensure consistent, effective, and efficient quality control activities aligned with department and organizational objectives.
* Assess, select, develop, and retain talent necessary to support the department and organizational objectives.
* Oversight of Calibration, GMP Audits for Retailers, Supplier Quality Sampling / Testing Programs, Stability Monitoring, COAs, and Internal Quality Metrics.
* Periodic communication of quality metrics to internal customers, including identification of deficiencies and initiation of actions to address. Provide quality metrics as inputs to Management Review/ Quality scorecard.
* Partner with Operations to drive quality culture, including training and education, communication, and activities to support the company quality policy.
* Support the Internal and External nonconforming material process, communicating with internal teams to ensure quality metrics are consistently met and escalating issues as needed. Ensure effective implementation and consistent application of the site nonconforming material process.
* Continuous improvement of site quality control systems to ensure effective and efficient controls for product quality.
* Coordinate responses to third party testing failures, including sample inspection, internal sampling and testing, and portal entry.
* Responsible for keeping current with, maintaining, reviewing, and implementing any applicable regulations and standards, supporting internal audits to various standards.
* Support effective implementation of all GMP requirements and understand how it affect products/processes supported and/or owned.

Experience Required

* Bachelor's Degree from an accredited institution in Engineering, Quality Engineering, or other technical fields
* Minimum of 10 years of experience in pharmaceutical industry, including 3 years in a leadership position. Quality leadership/medical device experience preferred.
* Working knowledge of applicable regulations and standards for medical device industry
* Strong understanding of statistically valid sampling practices with an ability to create sampling plans to meet specific needs
* Effective leadership, facilitation, and presentation skills, with the ability to function effectively in a team environment to gain the cooperation of individuals across the business
* Demonstrated ability to work with and manage internal resources and outside contractors.
* Strong analytic/problem solving skills with the ability to convert strategies into actionable plans and processes
* Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
* Strong verbal and written communication skills in English, with demonstrated ability to successfully work with peer group and frontline organization
* Proficiency with PC skills such as Word, Excel PowerPoint, and accounting software with the ability to quickly learn various in-house software applications
* Able to practice sound and ethical judgment with the ability to handle sensitive and confidential information and situations
* Able to work independently to deliver on multiple objectives and goals according to business commitments



Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo

Nearest Major Market: Grand Rapids
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