Quality Assurance Inspector III - 2nd shift

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

Quality Assurance Inspector responsible for day to day in process quality checks across manufacturing lines to ensure all Finished Goods meet product specifications

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Perform daily inspection of all production lines to assure compliance to GMPs and company. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete.
• Inspect work areas for removal or all previous products and components. Verify readiness of work areas prior to use (Line Clearance).
• Monitor, sample, and inspect in-process finished product for quality by performing appropriate tests. Collect data and samples to support disposition of product. Determine final disposition of products inspected and verify information on transfer tickets. Apply appropriate disposition label to material.
• Identify and notify Production and Quality when discrepancies from procedures and specifications are observed.
• Perform AQL inspections as required.
• Execute Rework protocols as required.
• Initiate/Login LIMS and Retain Samples.
• Print Specifications from AS400, create shop order packages, and provide to Production, as needed.
• Collect samples as required by customers or Nice Pak/PDI specifications and ship samples to customers, as required by the Manufacturing Instructions.
• Collect stability samples.
• Execute Trials and Validations.
• Review documentation to assure accuracy prior to submittal to QA Release team.
• Review Master Batch Sheets.
• Act as Lead QA Inspector in his or her absence to complete distribution of lines and ensure proper coverage of the production floor during the appropriate shift.
• Identify continuous improvement opportunities and promote a quality culture.
• Handle assignments as requested by supervision to establish and maintain product quality.
• Perform any required testing as per SOPs and WIs

PERFORMANCE MEASUREMENTS

• First time right on review of production jackets
• On-time completion of all training

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor's Degree or equivalent experience

REQUIRED KNOWLEDGE:

• Proficiency in Microsoft Office Suite

EXPERIENCE REQUIRED:

• 3+ Years of experience working in regulated industry

SKILLS/ABILITIES:

• Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization

WORKING CONDITIONS:

• Ability to lift 25 pounds

SALARY RANGE

• $40,000 - $60,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

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