Purpose:

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Provides essential business and system support for software systems and laboratory instrumentation. Collaborates with various departments to initiate and complete performance qualification (PQ) validation, facilitating the validation process and implementing system upgrades.

Essential Functions:

• Participate as a validation representative at project team meetings, completing assigned action items. Provide direction for future software releases and review change requests. Communicate proactively with all project team members, offering regular feedback to management concerning timeline, budget, or resource constraints.
• Guide future software releases and review change requests.
• Communicate with project team members, providing feedback on timelines, budgets, and resources.
• Support new releases and modifications throughout the software development life cycle by preparing validation plans, test cases, and documentation.
• Review PQ and change control documentation with leadership per SOP.
• Ensure test scripts meet functional requirements and business expectations.
• Complete test scripts to verify system performance and reliability.
• Manage data within the testing environment to accurately test software functionality.
• Address PQ-related issues from client or internal audits with leadership.
• Manage assignments to meet deadlines and produce high-quality work while staying updated on relevant regulations and SOPs.
• Identify user requirements and assist in system design and documentation.

Job Complexity:

Handles problems of moderate scope, requiring analysis of various factors.

Job Knowledge:

Develops professional expertise by applying company policies and procedures to resolve issues.

Supervision Received:

Receives general instructions for routine work and detailed instructions for new projects. Exercises judgment within defined procedures to determine appropriate actions.

Business Relationships:

Primarily interacts internally with occasional external customer/vendor contact on routine matters. Builds productive working relationships.

Qualifications:

Education and Experience:

• Bachelor’s degree or equivalent experience.
• 3+ years of relevant experience.

Knowledge, Skills, and Abilities:

• Strong interpersonal, oral, and written communication skills.
• Attention to detail and problem-solving skills.
• Proficiency with Microsoft Office Suite.
• Ability to learn new software with minimal instruction.
• Positive attitude and ability to work well with others.
• Effective organization and time management skills.
• Understanding of clinical trial processes and software development life cycle (SDLC).
• Troubleshooting skills and ability to analyze software defects.
• Knowledge of GCPs, SOPs/WPDs, and process maps.
• Ability to review and critique SDLC documentation.
• Proven ability to coordinate project activities and communicate within a multi-disciplinary team.

Management Role:

No management responsibilities.

Working Conditions and Environment:

Office environment with exposure to electrical office equipment.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movements.
• Ability to use various computer software.
• Effective verbal communication and comprehension skills.
• Frequent interaction with diverse groups.
• Ability to work independently and manage multiple tasks.
• Regular and consistent attendance.

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