Job Description

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Job Role: IT-QA

Work Location : Fall River, MA

Work Hours: General: 8:00AM – 5:00PM (May vary based on business needs)

Reports To : Site Quality Assurance Head

Salary Range : $67,000 – $95,000 -

PURPOSE

The purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that provides documented evidence of relevant details of specific events.

JOB DESCRIPTION

The IT- QA Associate position is an individual contributor role and a member of the Pharmaceuticals Quality Team. The position monitors changes to electronic records, alterations in critical parameters or any other actions that could impact product quality. This position reports to the Site Quality Head.

The job duties for this position include but are not limited to the following:

• Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part 11 requirements.
• Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely review and analyze the data to proactively address any emerging trends or areas for improvement.
• Provide comprehensive training to employees involved in the analytical laboratory related activities as well as manufacturing process who are entitled to use digital platforms for execution of GMP/GLP activities. Ensure that users understand the importance of audit trail integrity and data integrity and their role in maintaining accurate and reliable records and adhering to cGMP compliance.
• Provide support for investigation and implementation of CAPA related to such investigation.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• B.Sc. in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, etc).
• Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and audit of electronic data is must.
• Minimum of two (2) years’ experience in a quality assurance in a GMP environment specific Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization.
• Experience in MDI or DPI dosage form manufacturing preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Candidates must have an aptitude for quantitative problem-solving or advanced analytics.
• Ability to multitask efficiently, prioritize quickly, and manage time effectively.
• Candidates must have experience in writing and executing performance tests.
• Database and computer skills; talent for analyzing and visualizing complex data.
• Advanced proficiency with Microsoft Excel.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to prioritize tasks with strict deadlines.

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