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PDI · 3 weeks ago

Lead QA Inspector - 1st Shift

Orangeburg, New York, United States

Full-time

Onsite

Senior Level, Lead/Staff

$65K/yr - $70K/yr

3+ years exp

PDI is committed to research, quality, and service, providing innovative products and support to promote health and wellness. The Lead Quality Assurance Inspector is responsible for ensuring that all finished goods meet product specifications through daily inspections and monitoring of production lines.

Health CareMedicalMedical DeviceTraining

H1B Sponsor Likely

Responsibilities

Perform daily inspection of all production lines to assure compliance to GMPs and company. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete

Inspects work areas for removal or all previous products and components. Verifies readiness of work areas prior to use (Line Clearance)

Monitor, sample and inspect in-process, finished product, for quality, by performing appropriate tests. Determine final disposition on products inspected and verify information on transfer tickets. Apply appropriate disposition label to material

Execute Rework protocols as required. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Collects data and samples to support disposition of product. Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc

Initiation/Login of LIMS Samples. Notifies and follows through with production and Quality when discrepancies from procedures and specifications are observed. This function includes, but is not limited identifying non-conforming material, management of this material within BPCS (Hold procedure) recording of it and distributing required documentation

Collect samples as required by customers or Nice Pak’s specifications. This includes any retain sampling as per manufacturing specifications

Retain evaluation as requested

Execution of Validation Protocols

Review of documentation to assure accuracy prior to submittal to QA Release team

Identifies means for continuous improvement and to promote a quality culture

Identifies and works with the Lead to resolve problems in a timely manner, and supply alternate solutions

Handle assignments as requested by supervision to establish and maintain product quality

Perform any required testing as per SOPs and WIs

Qualification

Quality AssuranceGMP ComplianceMicrosoft Office SuiteRegulated Industry ExperienceOrganizational Skills

Required

High School Diploma

Proficiency in Microsoft Office Suite

3-5 Years of experience working in regulated industry

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

Ability to lift 25LBs

Preferred

College Preferred

Benefits

Plus bonus

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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2022 (1)