Under minimum supervision of the Manager, QC Information Systems, the QC Information Systems Specialist provides technical support for the QC Laboratory computerized systems and related processes. Ensures programs and processes are in place that align with the current regulatory requirements and guidance to mitigate laboratory data risk. Identifies opportunities for and coordinates with QC Management for continuous improvements in efficiency, training, equipment integration, software, control systems, and GMP compliance as related to laboratory data and information and other opportunities for improvement.Essential Duties and Responsibilites

• Reviews and determines software and hardware requirements for scheduling priorities and workload allocations for QC Department metrology.

• Works with laboratory management to assign responsibility for CAPA execution related to Information Systems and data integrity. Reviews all submitted laboratory CAPAs and investigations to discover failure trends. Investigates recurring types of failures to identify opportunities for improvement.

• Coordinates with Information Technology (IT) to ensure network infrastructure, computerized systems technologies, and related hardware/software/firmware are properly integrated and validated/qualified.

• Ensures laboratory SOPs, cGMPs, and laboratory safety rules are followed.

• In conjunction with laboratory management, reviews, edits, writes, or assists in writing SOPs for risk mitigation for laboratory computerized systems and data.

• Oversees LIMs component templates Change Control processes including design, testing, and validation.

• Maintains professional and scientific competence in laboratory information systems and troubleshooting by reading relevant literature and/or attending seminars, training sessions, workshops, or classes.

• Performs other duties as required.

Knowledge Necessary to Perform the Job:

• Knowledge of company laboratory and IT SOPs, cGMP regulations, USP methodology, FDA/MRA (Part 11/Annex 11), ICH, OSHA, GAMP5, and SDSs essential.
• Knowledge of computer operation and LIMS operation and architecture is essential.
• Knowledge of the operation of modern analytical instrumentation and software, including Empower Chromatography Software is required.
• Knowledge of computer system validation and electronic data security.
• Knowledge of fundamental concepts of analytical chemistry equipment principles.

Competency:
To perform the job successfully, an individual should demonstrate the following competencies:

• Problem Solving: Ability to troubleshoot technical issues and provide satisfactory resolution in a timely manner for software and network systems.
• Technical Skills: Versed in the application of computerized systems in a regulated industry. Familiar with hardware/software for standalone and enterprise systems. Some familiarity with the technical operation of analytical balances, HPLCs, GCs, UV/VIS Spectrophotometers, pH meters, FTIR, Karl Fischer Titrators, Automatic Titrators and other analytical equipment.
• Oral Communication: Effectively communicate with clients, vendors, and staff members from multiple departments, in a clear and concise manner.
• Written Communication: Completes documents/logs clearly and accurately. Writes clear and accurate technical documents.
• Ethics/Professionalism: Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor.
• Organizational Support: Supports organization’s goals and values. Follows policies and procedures.
• Adaptability: Ability to deal with frequent changes to schedules, delays, or unexpected events.
• Attendance/Punctuality: Maintains regular and punctual attendance.
• Initiative: Proactively identifies and resolves issues which have the potential to affect laboratoies operations or schedules.
• Quality: Produces technical work of high quality. Observes company quality policies and procedures.
• Safety and Security: Observes safety and security policies and procedures. Takes precautions in the use of energized systems and components, laboratory chemicals, pharmaceuticals, gas cylinders, and glassware handling.
• Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

To apply, send resume and salary requirements to:
humanresources@upm-inc.com

Pay: $38,804.98 - $46,732.88 per year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No weekends

Work Location: In person