Incoming Inspector I (1st Shift)

About the role

Responsibilities include visual and physical inspection of packaging, components, and bulk product related to contract packaging. Participation in internal, external, or regulatory audits is required at the discretion of senior management. The quality inspection process directly impacts company compliance with regulatory requirements and customer satisfaction.

Responsibilities

• Execute, document, and release evaluations of incoming components related to packaging processes, including customer-supplied, purchased, and internally produced components.
• Sample components and bulk products using guidelines established in standard operating procedures or item specifications.
• Perform and document required IR and Global Vision testing.
• Review and release the work of peers at the discretion of QA management.
• Participate in internal, customer, and regulatory audits as required.
• Train designated peers at management request.

Requirements

• Pass a colorblindness test to ensure ability to detect out-of-specification colors.
• Associate degree with 2–4 years of related experience, or Bachelor’s degree with 0–2 years of related experience, or High School Diploma with at least 4 years of related experience.
• Experience in inspection within the pharmaceutical or related industry is desired.
• Outside certification in basic quality skills and practices (e.g., ASQ CQT, CQIA, CQI) is desired.
• General knowledge of FDA regulations related to cGMPs is desired.
• General knowledge of quality control/assurance is desired.
• Strong documentation and communication skills.
• Strong organizational and planning skills.

Skills

• Ability to apply moderately complex mathematical operations, including understanding statistical sampling plans.
• Effective communication (written and verbal) with internal teams (Quality, Warehouse, Materials Management, Account Management) and external contacts (customer representatives, material suppliers).
• Thorough understanding of job aspects to make rational decisions regarding quality compliance and problem resolution.
• Proficiency in basic Windows applications, including Microsoft Office Suite. Experience with Lotus Notes and QAD is desired.

Physical Demands

• Frequent sitting to complete paperwork.
• Occasional standing, walking, and reaching with hands and arms.
• Occasional lifting and/or moving of up to 25 pounds.
• Specific vision abilities required: close vision, distance vision, and ability to adjust focus.

Work Environment

• Primarily desk-based with periodic visits to the shop floor.
• Clean environment, not normally subject to hazardous conditions.
• Moderate noise levels.