QA IT Analyst Position Available In Durham, North Carolina

QA IT Analyst Aurobindo Pharma USA, Inc.

Durham, NC Job Details Full-time Estimated:

$61K

• $77.

2K a year 18 hours ago Qualifications Management Process improvement Mid-level Data governance Bachelor’s degree Continuous improvement Certified Quality Auditor Organizational skills Computer skills Manufacturing Research & development 2 years

SDLC Full Job Description Division Overview:

Aurolife was founded in 2008 as part of a group of companies that have a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization have given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R D, Quality Assurance, Quality control, and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife aims to provide healthcare at economical prices to make the world a healthier place to live in.

Job Overview:

Review and approve validation deliverables associated with various Aurolife systems such as LIMS, Quality Assurance Management System (QAMS), Waters Empower, Document Management System, Training Management System etc.

Responsibilities:

Ensure key software development lifecycle (SDLC) processes, such as Change Control, Release, Deviations, etc. Review and approval of test scripts and defects associated with computer systems validation. Partner with IT to ensure risk assessments, incident management, and Oversight is aligned with corporate and data protection standards. Support internal and external regulatory inspection activities related to validated systems. Provide support to Quality Programs such as Data Integrity Governance, Investigations, training, and others on the assigned computerized systems. Ability to manage multiple projects, create and work within timelines, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team. Operate effectively and with minimal supervision, within a team or independently, performing special projects and duties as assigned. Follow the laid down Quality Culture Principles and Behaviors (CQA-CP-GEN-0139). QA IT Personnel will act as Admin to the Creation of user accounts, and Configure Settings and providing permission to the user in different software for Quality system, for example:

• DMS, QAMS, Nichelon, etc., but not limited to the mentioned Qualifications

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Skills & Requirements:

Proven expertise in reviewing and approving validation deliverables for key quality and laboratory systems such as LIMS, QAMS, Waters Empower, DMS, and Training Management Systems Well-versed in SDLC processes including Change Control, Release Management, and Deviation handling for validated systems Competent in test script and defect review/approval for system validation and ongoing compliance Strong collaboration with IT and cross-functional teams to ensure risk assessments, incident management, and system oversight adhere to corporate and data integrity standards Adept in supporting internal and external audits, inspections, and data integrity governance activities Hands-on experience managing user account setup, system configuration, and access control for QA IT systems Demonstrated ability to manage multiple projects simultaneously, meet deadlines, and communicate effectively in a team-based and independent work environment Committed to upholding quality culture principles and continuous process improvement

Education & Experience:

Bachelor’s Degree in a related field. Must have at least 2 years of related QA pharmaceutical experience

Physical Requirements:

OFFICE POSITION

• While performing the duties of this job the employee is required to:
• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required
• Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
• Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Additional Physical Requirements:

Job requires the use of his/her feet to operate foot controls or for repetitive movement Hand Manipulation is required

• Fine Manipulation Left Hand Hand Manipulation is required
• Fine Manipulation Right Hand Hand Manipulation is required
• Pushing & Pulling Left Hand Hand Manipulation is required
• Pushing & Pulling Right Hand Hand Manipulation is required
• Simple Grasping Right Hand Lifting 8+ Hours
• 0-10 Pounds Kneeling 8+ Hours Twisting 1-4 Hours Climbing 1-4 Hours Bending 5-8

Hours Blood/Fluid Exposure Risk:

Category III:

Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.