QA Line Inspector II

Key Responsibilities

• Provide quality oversight of all manufacturing operations, including line clearance, in-process inspections, label inspection and control, raw material/packaging release, environmental monitoring/reports, and sample retention
• Follows and completes training according to the assigned training curricula.
• Performs sampling for raw materials, packaging components, manufacturing components, and other materials as needed
• Performs GMP inspections and attribute inspections of materials, intermediates, and product according to the batch record, packaging record, specifications, and procedures
• Maintains safety and health of the work environment by following written standards and procedures, complying with applicable regulatory requirements
• Escalates potential issues and concerns immediately to QA and Operations management
• Initiates Change Controls, Investigations, Planned Deviations, CAPA and QA HOLDS as assigned
• Supports writing and trending documents using Office applications such as Word and Excel
• Maintains a safe and healthy work environment by following written standards and procedures, complying with applicable regulatory requirements

Requirements

• Minimum High School or Associate Degree
• Minimum of two (2) to (4) years of experience in nutraceuticals, or a combination of experience and education

Qualifications

• Basic knowledge and understanding of current Good Manufacturing Practices (cGMPs), as well as ICH and other regulatory requirements/guidelines, especially as they relate to nutraceuticals
• Ability to handle multiple priorities, maintain confidentiality, and interface with individuals from other departments
• Excellent verbal and written communication skills
• Proficiency in English usage, both verbal and written, spelling, grammar, and punctuation
• Flexibility and ability to multitask

Skills

• Establish sound positive working relationships and interact with different types of people on all levels of skill, background, and position is essential

Physical/Work Environment/Expectations

• Works within a GMP Manufacturing Environment, office environment and inside the plant
• Must be able to work in controlled environments requiring special gowning
• Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, hands, and arms
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments
• Pace may be fast and job completion demands may be high
• While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear
• The employee must occasionally lift or move up to 50 pounds