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AMRI

Director, Quality Operations

Albuquerque, NM · On-site

Direct the Incoming QA (IQA), Manufacturing QA (MQA), Aseptic Core Monitoring (ACM), Sterility Assurance, and Client QA teams to ensure that planned objectives are achieved * Develop and implement an ...

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How much do mqa jobs pay per year?

As of Jun 6, 2026, the average yearly pay for mqa in the United States is $149,680.00, according to ZipRecruiter salary data. Most workers in this role earn between $128,500.00 and $165,000.00 per year, depending on experience, location, and employer.

What are the typical daily responsibilities of an MQA specialist in a manufacturing setting?

An MQA specialist in manufacturing is primarily responsible for monitoring production processes, conducting quality inspections, reviewing documentation for compliance, and supporting internal audits. On a typical day, you may observe operations on the production floor, collect and analyze quality data, and collaborate with both production and engineering teams to address quality issues. You’ll also play a key role in maintaining records in line with regulatory requirements and contribute to root cause investigations when deviations occur. This hands-on and varied role keeps you involved in multiple facets of the manufacturing process, helping ensure high product standards are maintained at every stage.

What are the key skills and qualifications needed to thrive in the Mqa position, and why are they important?

To succeed as an MQA (Manufacturing Quality Assurance) professional, you need a solid understanding of quality control principles, regulatory compliance, and process improvement, often supported by a degree in engineering, life sciences, or a related field. Familiarity with industry standards such as ISO 9001, Good Manufacturing Practices (GMP), documentation systems, and quality auditing software is important. Strong attention to detail, critical thinking, and effective communication skills help you identify issues and collaborate across teams. These abilities are vital to ensuring product quality, regulatory compliance, and continuous improvement in manufacturing environments.

What is an MQA job?

An MQA (Manufacturing Quality Assurance) job involves ensuring that products meet regulatory and company quality standards during manufacturing. Professionals in this role oversee quality control processes, conduct audits, and implement compliance measures to maintain product integrity. They work closely with production teams to identify and resolve quality issues, ensuring efficiency and adherence to industry regulations. MQA roles are common in industries like pharmaceuticals, food production, and manufacturing.

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Mqa jobs near you
QA Manufacturing Specialist II/Senior (Day Shift)

QA Manufacturing Specialist II/Senior (Day Shift)

KBI Biopharma, Inc.

Durham, NC • On-site

$79K - $109K/yr

Full-time

Posted 15 days ago

Job description

Please Note: This is a day shift opportunity that follows a 2-2-3 schedule
Job Summary
The QA Manufacturing Specialist, Senior is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.
This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations. Client and regulatory audit/inspection support is also within job scope.
Job Responsibilities
  • Perform on-the-floor compliance review on executed records including batch records, equipment preparation records, and solution record and associated forms, in-process data, and logbooks.
  • Perform activities such as manufacturing walk-throughs, facility responses, label reconciliation, etc.
  • Support Manufacturing changeover process.
  • Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations, CAPAs, and other compliance issues in a timely manner
  • Support client audits and regulatory inspections and client batch record review process.
  • Support QA Raw Material group with release of raw materials
  • Able to react to change productively and handle other essential tasks as assigned.
  • Review document revisions (SOPs, Forms, Solution Records, etc)
  • Supports training of other Quality department staff to perform quality duties as needed.
  • Support process improvement projects to include improving the lifecycle of batch record review cycle times and batch release dates.

Minimum Requirements
  • MQA Specialist II: BS/BA in scientific field and 5 years experience or MS/MA degree and 3 years' experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.
  • MQA Senior Specialist: BS/BA degree in scientific field and 8 years experience or MS/MA degree and 6 years' experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.
  • Knowledge of US and EU cGMP guidelines/regulations is desired.
  • Experience with electronic document management systems, SAP and Microsoft Office suite are preferred.
  • Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
  • Knowledge of biopharmaceutical manufacturing including cell culture, protein purification, and single-use platform technology is preferred.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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