Quality Assurance Specialist IV
7555 Gateway Boulevard Newark, CA 94560 US
Job Description
JOB SUMMARY:
The Specialist IV provides compliance support or oversight for operational functions. This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control).
- Conducts investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis.
- Monitors completion of the quality system records and provides escalation to management, as needed.
- Generates and analyzes metrics for operational activities, including but not limited to laboratory investigations and invalid assays and other laboratory operation parameters as appropriate.
- Authors and/or revises other controlled documents such as procedures, methods, work instructions, protocols, and reports as applicable.
- Ensures personnel compliance of corresponding training programs for supported operational functions.
- 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).
WORK ENVIRONMENT and PHSYICAL DEMANDS:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 10 pounds at times.
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.
Education:
- Bachelor's in biology, biochemistry or related pharmaceutical-biotechnology discipline is required.
Pay Rate Range: $45-65/hr depending on experience
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