Quality Assurance E System Specialist

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: Quality Assurance E System Specialist

Location : Summit, NJ

Duration : 12 months (Possible Extension)

Job Description:

Required Competencies: Knowledge, Skills, and Abilities

Knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.

Knowledge of electronic batch records, Microsoft Word, Outlook, and Excel.

Requires ability to communicate appropriately with regulatory agencies.

Intermediate written and verbal communication skills.

Intermediate problem-solving, critical-reasoning, and decision-making skills.

Intermediate time-management, organizational, and multi-tasking abilities.

Ability to work independently for extended periods of time

Ability to interpret / write technical documents.

Ability to solve routine and complex problems.

Duties and Responsibilities

Maintain the quality, integrity, and compliance of company IT systems in order to help assure the safety and quality of products.

Provides input for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.

Drives use of best-practices during IT systems design, validation, and use.

Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.

Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.

Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.

Supports deviations as needed.

Represents Quality Assurance Operations for CAR T through the initiation and implementation of projects related to electronic systems.

Supports continual alignment of the business process with other business functions and provide effective on-going end user support.

Provide training to appropriate end users as related to enterprise system implementation and updates.

Drafts, reviews, and edits SOPs, process flow and other business documentation.

Performs all other tasks as assigned.