RCI-RT-34306814-Quality Assurance Specialist-Newark, CA at Rangam Infotech Private Limited

“Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.”


Does this position require candidate to drive?: Yes

JOB SUMMARY

• The Specialist IV provides compliance support or oversight for operational functions at Client
• 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.

ESSENTIAL DUTIES

• 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).

EDUCATION

Minimum Required:

• Requires a Bachelor’s degree 

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.
• Expertise in use of Microsoft Office applications.

 WORK ENVIRONMENT & PHYSICAL DEMANDS

• Repetitive motion, such as pipetting
• Must be able to lift up to 25 pounds at times