Quality Systems Specialist Jobs

JOB QUALIFICATIONS:

• Experience conducting root cause investigations and developing CAPA plans required
• Strong communication skills - verbal and written
• Strong technical writing skills required
• Knowledge of the principles and application of statistical analysis preferred
• Experience in quality system databases (Agile, web based applications) preferred
• Experience in database applications (e.g. Excel, Access) required
• Additional Preferred Skills: Strong organizational and communication skills in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization, including customers. Excellent time management skills. Experience as an internal or external auditor and in conducting investigations is preferred
• Minimum of 3 years’ experience in a Quality Assurance role within an FDA regulated manufacturing or distribution facility required
• Strong collaboration and teamwork
• Time management and ability to handle multiple tasks on time
• Specialized training in 21CFR 211, Part 11, and Q7A preferred
• Minimum of a B.S. degree, scientific or technical degree required

POSITION RESPONSIBILITIES:

• Oversees the change control process and development of change plans
• Creates quality system SOP’s to ensure compliance with PLD quality system and regulatory requirements
• Coordinates and oversees the deviation and CAPA system
• Tracks and trends exception documentation and develops and reports on quality metrics periodically
• Other necessary duties, as assigned
• Ensures CAPA plans are developed to eliminate root causes of nonconformances and ensure continuous improvement
• Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency
• Assists in customer complaint investiagtions and ensures responses are documented in a timely manner
• Assists in internal audits and ensures site preparedness for regulatory inspections
• Responsible for management of the record retention system
• Oversees the document control process

PHYSICAL REQUIREMENTS:

• This position is primarily sedentary, working at a desk or in attending meetings. No exposure to work hazards
• May involve standing for long periods of time
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements