Onsite GMP Quality, Validation & Contamination Lead

The FDA Group; Paso Robles (CA); On-site; USD 165,000 - 262,000; Part time

Job summary

The FDA Group in Central California is seeking experienced Pharmaceutical GMP Quality, Validation, and Contamination Control Consultants for urgent support at a pharmaceutical site in Paso Robles. You will work onsite on multiple workstreams including eQMS, change control, materials management, cleaning validation, and environmental monitoring.

Ideal candidates have hands‑on GMP experience, can independently drive deliverables, and are available for substantial onsite engagement in the Paso

Qualifications

• Significant experience in pharmaceutical manufacturing, GMP quality systems, validation, contamination control, or related technical compliance functions.
• Demonstrated hands‑on expertise in one or more of the identified workstreams.
• Strong working knowledge of applicable pharmaceutical cGMP requirements and regulatory expectations.
• Experience identifying manufacturing or quality system compliance gaps and developing practical corrective actions.
• Ability to prepare, review, and execute technical protocols, procedures, assessments, or validation documentation relevant to the assigned scope.
• Experience collaborating directly with Manufacturing, Quality, Validation, Engineering, and other site personnel.
• Ability to independently manage assigned deliverables and drive improvements through implementation.
• Availability to provide substantial onsite support in Central California.

Responsibilities

• Assess eQMS change control processes, documentation practices, record integrity, and accountability.
• Identify deficiencies involving change control assignments, extensions, tracking, documentation, and closure.
• Recommend improvements to corporate procedures and develop site‑specific supplemental documentation where appropriate.
• Support implementation of sustainable quality system improvements.
• Conduct onsite assessments of material receiving, warehousing, quarantine, storage, packaging, sterilization transfers, and shipping.
• Evaluate material segregation, traceability, sterile-product quarantine, and controls designed to prevent product mix‑ups.
• Identify GMP compliance risks associated with materials flow, manufacturing operations, and facility constraints.
• Review master batch records for cleaning, room release, line clearance, process controls, and traceability.
• Assess paper-based batch record controls, manufacturing documentation consistency, and Site Master File compliance.
• Develop and execute cleaning validation plans for manufacturing processes, cleanrooms, and associated equipment.
• Evaluate difficult‑to‑clean substances, process residues, product‑contact surfaces, sampling strategies, and analytical testing requirements.
• Prepare cleaning validation protocols, support execution, and complete final validation reports.
• Assess contamination control strategies against EU GMP Annex 1 and requirements applicable to terminally sterilized products.
• Review gowning, cleanroom cleaning, equipment cleaning, containment practices, and facility contamination controls.
• Evaluate contamination‑related risk assessments and recommend practical improvements.
• Review and support completion of the Validation Master Plan (VMP).
• Assess validation requirements for manufacturing processes, equipment qualification, test methods, and applicable supplier activities.
• Develop or refine User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) for building management and environmental control systems.
• Develop and execute validation protocols addressing temperature, humidity, pressure monitoring, and associated system functionality.
• Evaluate system data retention, data extraction, and retrospective validation considerations.
• Prepare technical validation documentation and final reports.
• Assess environmental monitoring practices and microbiological contamination risks.
• Support development of an environmental isolate program for growth‑promotion testing.
• Establish an objectionable‑organism list to support environmental monitoring investigations and out‑of‑specification assessments.
• Evaluate microbiological testing capabilities and identify technical or compliance gaps.
• Assess manufacturing readiness for advancement through GMP development and registration phases.
• Review phase‑gate requirements, readiness checklists, and supporting quality documentation.
• Evaluate process and equipment FMEAs, including PFMEAs.
• Strengthen risk assessments covering receiving, manufacturing, mixing, molding, assembly, packaging, sterilization, storage, environmental monitoring, and product returns.
• Evaluate sterile manufacturing risks and alignment with EU GMP Annex 1 expectations.
• Assess training needs related to potent‑compound handling and develop or improve supporting training materials and documentation.

Skills

GMP knowledge

Quality system implementation

Validation protocols

Contamination control

eQMS experience

Onsite coordination

Regulatory compliance

Tools

eQMS software

Documentation systems

Job description

The FDA Group in Central California is seeking experienced Pharmaceutical GMP Quality, Validation, and Contamination Control Consultants for urgent support at a pharmaceutical site in Paso Robles. You will work onsite on multiple workstreams including eQMS, change control, materials management, cleaning validation, and environmental monitoring.

Ideal candidates have hands‑on GMP experience, can independently drive deliverables, and are available for substantial onsite engagement in the Paso