Quality Assurance Specialist IV - West Coast Consulting

ONSITE

Provide technical writing in support of operational functions, such as Quality Control (QC).

Responsible for authoring Out of Specification (OOS) and anomalous event laboratory investigations, deviations, CAPA, and change controls.

Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and/or conducting investigations.

Conduct investigations thoroughly for OOS events according to the phase-based approach per FDA and Annex guidelines.

Investigate deviations to identify root cause and contributing factors and in parallel assess impact to patients, product quality, data integrity, validated state, and regulatory compliance.

Identify and develop relevant and effective CAPA.

Address impact to systems, processes, product, and any regulatory requirements when authoring change controls.

Prioritize and monitor completion of lab investigations, deviations, CAPA, and change controls.

Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines.

Generate and analyze metrics as applicable.

Manage and author change controls related to qualification, modification, and/or decommissioning of equipment.

Possess a strong understanding of data integrity principles.

Ensure compliance of personnel with corresponding training program(s).

 

EXPERIENCE: 

A minimum of 3 years work experience within a GMP environment working with small and/or large molecules.

Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC (Waters Empower software is preferred), and Relative Potency Assay.

Solid technical training and troubleshooting experience are essential.

Strong understanding of data integrity principles within a GMP environment is required.

 

PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER):   

Expertise in use of Microsoft Office applications.

 

Required

DISABILITY

BIOTECHNOLOGY

QUALITY SYSTEM

WESTERN BLOT

LABORATORY

 

Additional

GMP

QUALITY ASSURANCE

ELISA

QUALITY CONTROL

ROOT CAUSE ANALYSIS

FDA

DATA INTEGRITY

THERAPEUTIC

MICROSOFT OFFICE

BIOCHEMISTRY

TRAINING PROGRAMS

METRICS

RISK ANALYSIS

CORRECTIVE AND PREVENTIVE ACTION

HPLC

REGULATORY COMPLIANCE

 

Education:   Bachelor's in biology, biochemistry or related pharmaceutical-biotechnology discipline is required.

 

Job Category: Quality and Regulatory

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