Inspector, Quality

Key Responsibilities

• Perform scheduled line checks, verifying correct filling equipment, production supplies, assembly, settings, and batch signage.
• Collect samples and verify container, components, and over-pouch meet quality standards.
• Verify accuracy and legibility of print on samples and check for indications of leakage.
• Examine and verify packaging equipment performance meets quality standards.
• Test and confirm equipment passes/fails batch information and product properly.
• Collect samples of produced materials (membranes, bags, tubing, frangibles) and visually inspect for irregularities.
• Verify dimensions of produced materials are within specification.
• Perform seal integrity testing on produced materials.
• Employ testing methods such as freeze mode, destructive oven testing, and striation testing.
• Make minor operational decisions and provide direction/guidance in the absence of the Quality Associate.
• Train and act as a resource to other Quality Inspectors.
• Participate on teams to drive improvement to processes and equipment.
• Assist in investigations of exceptions and out-of-limits situations.
• Transport samples to and from the work area with a Powered Industrial Truck (PIT).
• Document and initiate the exception process using the Production Operations Management System (POMS) to research and provide details.
• Record checks and results into POMS.
• Write and submit changes to a Standard Operating Procedure (SOP) document when a process needs an update.
• Enter exception data into a spreadsheet for trending and reporting.
• Participate in the validation process for new equipment, equipment changes, and new processes by performing product testing and reporting results.
• Notify the supervisor and take appropriate action for safety, quality, or discrepancy issues.
• Learn, understand, and apply rigorous quality standards, SOPs, and Current Good Manufacturing Practices (cGMP).
• Sustain a clean and safe work area using 6S principles, including maintaining and securing provided tools.

Requirements & Tech Stack

• High School Diploma, GED, or equivalent.
• At least 18 years of age.
• Basic English written and oral communication skills.
• Minimum of 6 months experience on a production floor or in a quality control role preferred.
• Basic competency with the Microsoft Office Suite (Excel, Word, PowerPoint, etc.).
• Understand verbal and written safety and quality instructions.
• Read and comprehend written work instructions, including words and drawings.
• Basic mathematics.
• Proficient in use of measurement tools (Caliper, Micrometer, Ruler, etc.) and basic hand tools.
• Possess or be able to obtain Work saver Operator Certification.
• Ability to pass the P.I.T. physical.

Work Environment

• May include working in a Class I, Class II, Class III, or Class IV Controlled Environment.
• May require specific dress/gowning: safety glasses, ear plugs, hairnet, beard cover, isolation mask, gown, hood, boots or shoe covers, and gloves.
• Constant or intermittent noise and vibration.
• Working around moving equipment, machinery, and conveyors.

Physical Requirements

• Ability to stand/walk continuously throughout the shift.
• Ability to lift and carry up to 25 pounds.
• Normal visual acuity and ability to distinguish color.
• Ability to squat, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist, and balance.