Quality Assurance Inspector III - 1st Shift

About the role

The Quality Assurance Inspector III plays a crucial role in ensuring that all products manufactured on the production floor meet required quality, regulatory, and customer standards. This role involves performing daily in-process inspections, testing, documentation review, and line clearances to verify compliance with GMPs and manufacturing specifications. The Inspector collaborates closely with Production and Quality teams to identify discrepancies, support sample collection and rework activities, and assist with trials and validations.

Responsibilities

• 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).
• 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.
• 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.

Qualifications

• Education/Certification: Associate’s Degree in a scientific, technical, or related field, or equivalent combination of education and experience.
• Required Knowledge: Strong understanding of Good Manufacturing Practices (GMPs), quality systems, and regulated manufacturing environments. Working knowledge of AQL inspection standards, sampling plans, and in-process quality control methods. Familiarity with batch documentation, manufacturing specifications, and component/label verification. Proficiency in Microsoft Office Suite (Word, Excel, Outlook); ability to learn and operate quality-related systems such as LIMS, ERP, and electronic documentation tools.
• Experience Required: Minimum 3+ years of experience in a regulated industry (e.g., FDA, EPA, ISO), preferably in manufacturing or quality assurance roles. Demonstrated experience performing in-process quality inspections, line clearances, material disposition, and documentation review. Experience supporting trials, validations, rework activities, and sample collection for customers, retains, or stability programs. Prior exposure to continuous improvement, deviation identification, and collaboration with Production/Quality teams.
• Skills/Abilities: Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records, and product specifications. Excellent documentation accuracy, attention to detail, and commitment to “first-time-right” execution. Ability to conduct inspections, testing, and sampling with a high degree of consistency and objectivity. Effective communication skills with the ability to escalate discrepancies and collaborate across Production, Quality, and other cross-functional teams. Solid organizational, multitasking, and time-management skills to ensure efficient coverage of manufacturing lines. Ability to take initiative, identify improvement opportunities, and support a quality-focused culture. Leadership capability to act as Lead QA Inspector when needed and coordinate inspection coverage on the production floor. Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization.

Performance Measurements

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

Benefits

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)
• Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance
• PDI is committed to helping our associates maintain a healthy and sustainable work/life balance and is proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options