QA Line Inspector II

Quality Assurance (QA) Line Inspector II

The Quality Assurance (QA) Line Inspector II will provide quality oversight of all manufacturing and packaging operations as trained and assigned. The QA Line Inspector II will work collaboratively with the site operations and management to ensure adherence to SPI procedures, regulations, guidelines, and standards.

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
• Performs sampling for raw materials, packaging components, manufacturing components, and other materials as needed
• Follows and completes training according to the assigned training curricula. Only performs activities for which the Line Inspector II has been trained
• Performs GMP inspections and attribute inspections of materials, intermediates, and product according to the batch record, packaging record, specifications, and procedures
• Monitors all aspects of manufacturing, processing, and packaging operations, documenting inspection results by completing records and logs as required by procedures
• Initiate Change Controls, Investigations, Planned Deviations, CAPA and QA HOLDS as assigned
• Provide support to write and trend documents using Office applications such as Word and Excel
• Maintains safe and healthy work environment by following written standards and procedures, complying with applicable regulatory requirements
• Escalates potential issues and concerns immediately to QA and Operations management
• Performs any other duties which may be properly assigned to this position
• Other duties as assigned

Education and Experience

Minimum High School or Associate Degree.

Minimum of two (2) to (4) years of experience in pharmaceuticals, or a combination of experience and education

Knowledge, Skills, and Abilities

Basic knowledge and understanding of current Good Manufacturing Practices (cGMPs), as well as ICH and other regulatory requirements/guidelines, especially as they relate to pharmaceuticals.

Must have the ability to handle multiple priorities, maintain confidentiality, and interface with individuals from other departments.

Ability to establish sound positive working relationships and interact with different types of people on all levels of skill, background, and position is essential.

Excellent verbal and written communication skills.

Proficiency in English usage, both verbal and written, spelling, grammar, and punctuation.

Requires flexibility and ability to multitask

Physical/Work Environment/Expectations

This position 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. Specific vision abilities required by this job include close vision

Note: This job description is not totally inclusive nor is it designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.