Operations Research Analyst jobs in Goose Creek, SC

POSITION SUMMARY: Provides support for required functions involving hardware and software requirements and technical specifications for use in Quality (Quality Assurance and Quality Control). Supports coordination with the system vendor for system configuration and troubleshooting issues, data reporting, authoring SOPs, and ensuring system cGMP compliance for the Quality Systems and QC Laboratory functions. Facilitates and supports improvements to the business processes using electronic systems.

 RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.

• Supports the design and implementation of new or revised methods, workflows, or processes to meet or improve QA and QC Laboratory operations.
• Serves as Subject Matter Expert (SME) to assist and provide support to end users for new/existing software functions and/or modules as they apply to LIMS (laboratory Information Management Systems) and other systems used in QA and Quality Control.
• Assists users with issues, troubleshoots software-related errors and coordinates with system vendor and/or IT to assist with corrections, as needed.
• Assists in the updates to outward-facing Certificates of Analysis (OFCOA); supports OFCOA template validation.
• Supports Excel data validation.
• Supports software validation activities in QA and the QC Laboratories.
• Ensures compliance with software testing and validation requirements.
• Ensures data integrity standards.
• Provides staff training prior to the implementation of new systems, changes and modifications to the systems as needed, with QA/QC Lab Management approval.
• Aids in the creation of SOPs or other required documentation for the systems.
• Duties include other support for instruments and related software that interact with the lab systems.
• Assists with the validation of system improvements (drafting OQ and PQ protocols and execution of protocols).
• Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policies and procedures.
• Troubleshoots or carries out actions per scheduled or unscheduled maintenance.
• Adheres to company safety requirements.
• Seeks formal and informal performance assessments, including performance versus expectations and goals, behaviors, and leadership potential.