Quality Specialist Jobs in Miami, FL
Quality Specialist jobs in Miami, Florida draw steady demand from healthcare, life sciences, and international trade, with hiring concentrated in Brickell, Doral, and the Health District. Employers posting roles right now include University of Miami, Sofie, and Ware Malcomb. Find a role that fits below and apply directly.
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Job Description | Quality Assurance Specialist (QAS) I
Title | Quality Assurance Specialist I
Department | Quality/Regulatory/EH&S
Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)
Compensation $30-$33 Hour
Overview
The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.
Essential Duties and Responsibilities
- Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
Ensure that personnel are properly trained and qualified. Ensure that the training is documented.
Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).
Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.
Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.- Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., owning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
Ensure any deviations from normal procedures are documented and justified.
Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).
Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.
Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.
Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.
Expected extensive knowledge of up to two SOFIE products
Other responsibilities as required.
Qualifications
- Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.
Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
Quality, Pharmacy, or CGMP manufacturing experience preferred.
Knowledge of USP, FDA, and cGMP regulations preferred.
Knowledge of how and ability to write, review, and revise SOPs required.
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure
Ability to write reports, business correspondence, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients,
Ability to define problems, collect data, establish facts, and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficient in MS Office applications required.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
Requirements for Quality Assurance Specialist (QAS) I
- Associate’s or Bachelor’s Degree, at minimum
Relevant certifications and/or experience may be substituted in lieu of this requirement
1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience
Job Description | Quality Assurance Specialist (QAS) I
Title | Quality Assurance Specialist I
Department | Quality/Regulatory/EH&S
Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)
Compensation $30-$33 Hour
Overview
The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.
Essential Duties and Responsibilities
- Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
Ensure that personnel are properly trained and qualified. Ensure that the training is documented.
Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).
Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.
Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.- Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., owning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
Ensure any deviations from normal procedures are documented and justified.
Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).
Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.
Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.
Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.
Expected extensive knowledge of up to two SOFIE products
Other responsibilities as required.
Qualifications
- Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.
Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
Quality, Pharmacy, or CGMP manufacturing experience preferred.
Knowledge of USP, FDA, and cGMP regulations preferred.
Knowledge of how and ability to write, review, and revise SOPs required.
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure
Ability to write reports, business correspondence, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients,
Ability to define problems, collect data, establish facts, and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficient in MS Office applications required.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
Requirements for Quality Assurance Specialist (QAS) I
- Associate’s or Bachelor’s Degree, at minimum
Relevant certifications and/or experience may be substituted in lieu of this requirement
1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience
See All 11 Quality Specialist Jobs in Miami
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Find Quality Specialist JobsQuality Specialist Job Market in Miami
Who's Hiring
Top Industries Hiring
- Education
- Aerospace & Defense
- Healthcare & Medical Services
Quality Specialist Jobs in Miami: Frequently Asked Questions
How do I get a quality specialist job in Miami?
Focus your search on Miami's strongest hiring sectors: healthcare systems and hospitals in the Health District, medical device and pharmaceutical companies in Doral, and logistics and trade firms near the Port of Miami. Candidates who pair ISO or regulatory compliance experience with bilingual English-Spanish communication skills stand out in this market, where many employers operate across Latin American supply chains and deal with multilingual teams daily.
Which companies hire quality specialists in Miami?
Miami quality specialist roles are posted by University of Miami, Sofie, and Ware Malcomb and others right now, based on current listings on Migrate Mate as of July 2026. Miami's employer mix skews toward hospital networks, international freight and logistics companies, medical device manufacturers, and consumer goods distributors that require ongoing quality and compliance oversight.
Are there remote quality specialist jobs in Miami?
Yes, though options are limited since most quality specialist work involves hands-on audits, production floor oversight, or physical document review. About 50% of quality specialist openings tied to Miami are remote or hybrid as of July 2026, concentrated in roles focused on documentation, supplier auditing, and quality management system administration rather than direct manufacturing or clinical inspection work.
How can I get a quality specialist job in Miami with little or no experience?
The most realistic entry path in Miami is a quality technician or quality inspector role with one of the city's medical device or healthcare supply companies, particularly those in Doral or the Health District that hire for contract and temp-to-hire positions. Earning a foundational credential like a Six Sigma Yellow Belt or ASQ Certified Quality Improvement Associate strengthens your application, and bilingual Spanish fluency gives you a concrete edge with Miami employers who manage Latin American supply chains.
Which industries hire the most quality specialists in Miami?
Most quality specialist openings in Miami sit in Education, Aerospace & Defense, and Healthcare & Medical Services, per current listings on Migrate Mate as of July 2026. Miami's position as a hub for international trade, healthcare services, and medical manufacturing drives consistent demand for quality professionals who can meet both domestic regulatory standards and the compliance requirements of cross-border operations.
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See All 11 Quality Specialist Jobs in Miami
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