Lead QA Inspector - 1st 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

* This position is for 1st Shift (Mon-Fri, 7:00am - 3:30pm)* The Lead Quality Assurance Inspector responsible for day to day in process quality checks across manufacturing lines to ensure all Finished Goods meet product specifications. The Lead QA Inspector will also assign and balance work across their assigned shift.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

* Perform in-process and finished product inspections across manufacturing lines to ensure compliance with cGMP, SOPs, WIs, and product specifications.

* Verify line clearance and readiness of production areas prior to use.

* Monitor, sample, and test materials and finished goods; determine disposition and ensure appropriate documentation and labeling.

* Execute rework protocols and support disposition activities as required.

* Initiate and manage LIMS samples and documentation, and identify, document, and communicate non-conforming material in accordance with hold procedures.

* Collect required product, reserve, and customer samples per manufacturing specifications.

* Provide day-to-day coordination and guidance to QA Inspectors during the shift, including assigning and balancing workload as needed.

* Step in to perform inspection, documentation, or system-entry activities during high-volume periods or when coverage is needed.

* Review QA documentation for completeness and accuracy prior to submission to the QA Release team.

* Participate in production and quality meetings, including daily coordination meetings and Gemba walks.

* Provide coaching and instruction to QA Inspectors to support consistent execution of quality procedures and documentation practices.

* Support continuous improvement initiatives and promote a strong quality culture across the manufacturing floor.

* Support QA operational activities including inspection tracking tools, logbooks, sample coordination, production order support, and other quality documentation and administrative tasks required to maintain inspection readiness and compliance.

* Provide support for validation and trial activities across the manufacturing floor.

* Lead training and onboarding efforts for new hires to ensure successful integration, competency development, and adherence to quality and compliance standards.

* Proven ability to communicate and collaborate with cross-functional stakeholders at all organizational levels, including senior management, and to represent the Quality Department with credibility and professionalism during external audits and regulatory interactions.

PERFORMANCE MEASUREMENTS

* On time release of product

* First time right on completion of Quality Paperwork (DIR's)

* On time completion of all training

QUALIFICATIONS

EDUCATION/CERTIFICATION:

* Associates Degree or equivalent relevant experience

REQUIRED KNOWLEDGE:

* Proficiency in Microsoft Office Suite

EXPERIENCE REQUIRED:

* 5+ years of experience working in regulated industry

SKILLS/ABILITIES:

* Proven ability to communicate and collaborate with cross-functional stakeholders at all organizational levels, including senior management, and to represent the Quality Department with credibility and professionalism during external audits and regulatory interaction

* Excellent organizational skills

WORKING CONDITIONS

* Ability to lift 25LBs

SALARY RANGE

* $65,000 - $70,000 annually, plus bonus

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

* 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

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

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