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PDI · 5 hours ago

QA Inspector III - 2nd Shift

Orangeburg, NY

Full-time

Onsite

Mid, Senior Level

$55K/yr - $60K/yr

3+ years exp

PDI is a company committed to research, quality, and service, providing innovative products and resources to promote health and wellness. The Quality Assurance Inspector III ensures that all products meet quality and regulatory standards through inspections, testing, and collaboration with production teams.

Health CareMedicalMedical DeviceTraining

H1B Sponsor Likely

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). 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

Qualification

Manufacturing PracticesAQL inspection standardsQuality control methodsLIMS proficiencyMicrosoft Office SuiteRegulated industry experienceEffective communicationAttention to detailLeadership capabilityOrganizational skills

Required

Associate's Degree in a scientific, technical, or related field, or equivalent combination of education and experience

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

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

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

Ability to lift 25 lbs

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)

Legal assistance

Critical illness

Hospital indemnity and accident coverage

Discounted home/auto/rental insurance

Employee discounts

Pet insurance

Sick leave

Generous vacation and holiday time

Paid parental leave

Summer hours

Flex place/flex time options

Company

PDI

PDI is dedicated to leading the fight against preventable infections in healthcare, foodservice and our communities.

Founded in 1977

Woodcliff Lake, New Jersey, USA

1001-5000 employees

https://wearepdi.com

H1B Sponsorship

PDI has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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