Job Details

Description

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