Quality Systems Specialist

JOB SUMMARY

The Quality Systems Specialist I will be responsible for maintaining the company's document control and training programs. Working closely with direct management to support the company's quality programs as well as perform administrative tasks for the QA Department.

SHIFT

Monday - Friday 2nd Shift

PRIMARY DUTIES AND RESPONSIBILITIES

• Process all internally created documents such as Methods, Standard Operating Procedures (SOPs) and correspondences.
• Maintain and archive the Quality files in an efficient manner.
• Assist other Quality personnel as required.
• Scan all documents and ensure scans are uploaded in Reliance Quality management system.
• Administrator functions for enterprise systems used for document control.
• Run routine Qualtrax reports.
• Assist QA auditor with documentation retrieval and administration during Client and Regulatory audits.
• Assist with the revision of Standard Operating Procedures when needed.
• Assign Training in Reliance (i.e. assign / remove employee training requirements).
• Process all tickets in a timely manner.

REQUIREMENTS & QUALIFICATIONS

Qualifications include an associate's degree with 2+ years of related experience or a bachelor's degree in a related field. Good computer skills, such as MS office software is required. Basic knowledge of scientific terms, concepts and acronyms useful. Knowledge of the regulations of the Food and Drug Administration, compliance with Good Manufacturing Practices and pharmaceutical analyses is preferable.

MINIMUM SKILLS REQUIREMENTS

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