Quality Assurance Specialist: Product Inspection and Release

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that all products meet the highest standards of quality and safety.

Responsibilities

• In-process inspection of products as prescribed by First Article and In-Process Inspection procedures assigned by the Lead Inspector.
• Conduct daily dimension checks as required by department procedures or Lead Inspector.
• Carefully document inspection results on Inspection sheets maintaining GMP requirements.
• Conduct SPC, Vision System, and Leak Detection system validation as required by department procedures.
• Inspect line clearance as assigned by Lead Inspector.
• Release all product manufactured in the assigned shift using DC Link as per department procedures.
• Release reworked product using DC Link per department procedures.
• Identify and control non-conforming material as per company procedures, conduct backtracking for non-confirming product to assure all suspected ware has been isolated.
• Document inspection results in QA log book.
• Communicate non-conforming product information to shift supervisor, lead inspector, and group leads.
• Facilitate dock audits and Tailgate sampling as defined by the department procedure.
• Issue Quality Alerts if necessary.
• Responsible for maintaining a safe and clean environment.
• Maintains files and related duties as assigned.
• Observe and assure GMP compliance during in-process inspection.
• Other duties as assigned by QA Manager.

Qualifications

• Basic Math skills (add, subtract, divide, multiply and work with numbers up to 4 decimal places); numerical sequence of box labels.
• Working knowledge of Microsoft Word, Excel, and Access database, Lotus Notes.
• Must be able to speak, write, and read effectively in order to understand packing labels, safety posters, and other forms of written communication.
• Good vision and manual dexterity.
• Must be able to follow both verbal and written instructions.
• Good interpersonal skills.
• Ability to do accurate and concise reports.
• Attention to detail.

Work Environment

• Must be able to work eight (8) hours per day with two 15-minute breaks, and one 30-minute lunch.
• Must be able to work overtime on short notice.
• Obsolete climate control.
• Noise level is usually 90dB.
• Some fumes on the Production floor are from plastic, cleaning solvents, and oils when headed.
• Must wear a protective foot covering, such as rubber-soled steel-toed safety shoes.
• Must also wear earplugs, hairnets, bump caps, and beard guards when on the production floor.
• No jewelry except a wedding band without stones.
• Will lift cartons frequently, of various weight up to 45 lbs; 1 box every 5 minutes pulling down, lifting up, stacking, and moving.
• Both arm activity to lift boxes frequently; single arm activity occasionally to do cutting and measuring.
• Ability to visually detect difference in color, depth perception, flaws in product, letter sharpness, and read print.
• Required to read labels on cartons, Bill of Materials, pack patterns, and other QA-related paperwork.
• Must be able to access all ground area of production floor, to move from station to station, and get to height of work area.
• Constant bending and twisting are required on the average of 20% of the day.
• Required to stand most of the day with occasional sitting to do measurements and paperwork.
• Must be able to work nine (9) hours per day, five hours per week.
• Extended hours may be necessary.
• Must be able to wear PPE, such as hairnet, beard net (if applicable), rubber sole shoes, earplugs, and safety glasses.
• No jewelry allowed on plant floor except wedding band without stones.
• Single arm movement for writing, reading computer operation, calculator, and copy machine.
• Good visual acuity, ability to read printed material up to 1-hour intervals at computer screen.
• Must have good interpersonal skills, ability to interact with all employees, outside contacts, and counterparts throughout the organization.