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Cgmp Consulting Jobs (NOW HIRING)

Deloitte

V&V Functional QA Sr. Consultant

San Jose, CA · Hybrid

Ensure all V&V documentation meets 21 CFR Part 11, cGMP, and GAMP 5 standards including electronic ... As an experienced Verification & Validation Test Lead Senior Consultant you will have the ability ...

Deloitte

V&V Functional QA Sr. Consultant

San Jose, CA · On-site

Ensure all V&V documentation meets 21 CFR Part 11, cGMP, and GAMP 5 standards including electronic ... As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP.

Cryoport Systems, LLC

Validation Engineer

Irvine, CA · On-site

$108 - $132/hr

Position Summary The Validation Engineer - Consulting Services will support the Consulting Services ... Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred. * Experience using ...

Ubertal Inc

Medical Director

Hamilton, OH · On-site

Fulfill or delegate CLIA roles (laboratory director/technical or clinical consultant) and ensure CLIA/COLA training, proficiency testing, and standardization logs are completed. * Uphold cGMP ...

Frey Consulting Group

Manufacturing Engineer

Albany, OH · On-site

$90 - $130/hr

Basic understanding of cGMP or regulated industry practices * Strong troubleshooting and problem-solving skills * You bring a positive, professional attitude and can communicate and collaborate with ...

Ubertal Inc

Medical Director

Jackson, MI · On-site

... consultant); ensure CLIA/COLA training, proficiency testing (hematocrit, total protein), and standardization logs are completed. * Uphold cGMP standards in partnership with center management and ...

BEPC INC

Be Seen First

Drug Manufacturing Technician

Des Plaines, IL · On-site

$21 - $23/hr

This is an excellent opportunity for someone looking to build experience within a cGMP ... tier consulting and staffing solutions across industries like technology, engineering ...

Cryoport

Validation Engineer

Irvine, CA

Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting ... Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred. Experience using Excel ...

Cryoport, Inc.

Validation Engineer

Irvine, CA · On-site

Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting ... Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred. * Experience using ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer ... cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system ...

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Cgmp Consulting information

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How much do cgmp consulting jobs pay per year?

As of Sep 1, 2026, the average yearly pay for cgmp consulting in the United States is $80,827.00, according to ZipRecruiter salary data. Most workers in this role earn between $50,000.00 and $105,500.00 per year, depending on experience, location, and employer.

What is cGMP consulting?

cGMP consulting refers to professional advisory services that help pharmaceutical, biotechnology, and related industries comply with current Good Manufacturing Practices (cGMP) regulations. These consultants provide expertise in regulatory requirements, quality assurance, process improvement, and inspections to ensure that manufacturing processes meet FDA or international standards. cGMP consultants can assist with audits, training, documentation, and remediation to help companies maintain compliance and avoid regulatory issues.

What are the key skills and qualifications needed to thrive as a cGMP consultant?

To excel as a CGMP Consultant, you need a solid background in pharmaceutical or biotech manufacturing, in-depth knowledge of current Good Manufacturing Practices (CGMP), and often a relevant science or engineering degree. Familiarity with regulatory databases, quality management systems (QMS), and certifications like Six Sigma or ASQ-CQA is highly beneficial. Strong analytical thinking, communication, and problem-solving skills help you effectively guide clients through regulatory compliance and process improvements. These skills are vital to ensure product quality, regulatory adherence, and the successful implementation of best practices within client organizations.

What are some common challenges faced by professionals in cGMP consulting, and how can they be addressed?

CGMP consultants often face challenges such as staying current with evolving regulations, managing client expectations, and adapting best practices to diverse manufacturing environments. To address these, consultants must engage in ongoing professional development, maintain strong relationships with regulatory bodies, and develop tailored compliance strategies for each client. Effective communication and proactive problem-solving also help ensure successful project outcomes and build client trust.

What does cGMP Consulting do?

cGMP consulting involves providing expertise to ensure pharmaceutical, biotech, and medical device companies comply with current Good Manufacturing Practices (cGMP) regulations. Consultants assist with quality systems, validation, audits, and regulatory submissions to maintain product safety and compliance standards.
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Cgmp Consulting jobs near you
Infographic showing various Cgmp Consulting job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $80,827 per year, or $38.9 per hour.

Specialist QA

Juncos, PR • On-site

BioPharma Consulting JAD Group
Biotechnology Research and Development • 51 - 200 employees
Learn more about BioPharma Consulting JAD Groupexternal

Full-time

Re-posted 14 days ago

Job description

The Specialist QA performs a broad range of Quality Assurance activities under minimal supervision, ensuring compliance with cGMP requirements, internal procedures, and regulatory expectations. This role provides on‑the‑floor oversight, documentation review, quality system support, and cross‑functional collaboration to maintain product quality and operational excellence.

FUNCTIONS

  • Review and approve product MPs, process validation protocols, and manufacturing reports.
  • Perform on‑the‑floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, batch records, MES/EBR, SAP, EDMQ, DQMS, Trackwise documentation, deviations, CAPAs, and validations.
  • Participate in incident triage teams and ensure deviation initiation, documentation, and procedural compliance.
  • Approve Environmental Characterization reports and release sanitary utility systems.
  • Approve planned incidents, NC investigations, CAPA records, and change controls.
  • Lead investigations, audits, and support internal/external inspections as part of the audit management team.
  • Represent QA in New Product Introduction (NPI) activities and provide quality oversight for new products.
  • Own and maintain site quality program procedures; act as designee for QA leadership on CCRB.
  • Review risk assessments and support automation, facilities, environmental, and engineering programs.
  • Review and approve Work Orders and EMS/BMS alarms.
  • Provide lot disposition and authorize lots for shipment.
  • Ensure production records and testing results are complete, accurate, and compliant with cGMP.
  • Coordinate testing with contract laboratories and vendors; review external lab data for accuracy and compliance.
  • Support commissioning, qualification, and validation activities (IQ/OQ/PQ, Validation Master Plans, protocols, test scripts, summary reports).
  • Serve as a strategic advisor regarding quality, compliance, supply, and safety risks.
  • Champion continuous improvement initiatives, programs, and projects.
  • Maintain adherence to assigned training requirements.
  • Collaborate cross‑functionally with Manufacturing, Process Development, Validation, QC, Warehouse, Engineering, Facilities, Environmental, Contractors, and other stakeholders.

Requirements

EDUCATION

  • Doctorate OR
  • Master’s + 2 years of directly related experience OR
  • Bachelor’s + 4 years of directly related experience OR
  • Associate’s + 8 years of directly related experience OR
  • High School/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS

  • Experience in Change Control, Documentation Review, Validation, PPQ.
  • Demonstrated expertise in Quality Systems (deviations, CAPA, change control).
  • Experience with computer systems validation or computer systems QA (medical device or consulting background preferred).
  • Strong knowledge of manufacturing, distribution, QA, QAL, and Process Development processes.
  • Experience with GxP application validation and compliance documentation.
  • Proven ability to lead, influence, and negotiate across teams.
  • Strong organizational skills and ability to follow assignments through to completion.
  • Ability to interact effectively with regulatory agencies.
  • Strong communication skills in English and Spanish (written and oral).
  • Advanced data trending, evaluation, and compliance assessment skills.
  • Ability to work independently and interact effectively at all organizational levels.

Benefits

  • Administrative shift.
  • 6‑month contract with possible extension.