- Title: Quality Assurance Specialist
- Code: RCI-8841
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 12/02/2019
- Duration: 12 Months
The Quality Assurance eSystem Specialist’s primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. The Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of products.
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.
Education and Experience
- Bachelor’s degree preferred, preferably in Science or Engineering.
- 3 years’ relevant work experience required in the pharmaceuticals or related industry.
- 1 year of experience supporting electronic quality systems.
- An equivalent combination of education, experience and training may substitute.
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.