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Lead QA Inspector
2 weeks ago
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 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.
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:
- High School Diploma; College Preferred
REQUIRED KNOWLEDGE:
- Proficiency in Microsoft Office Suite
EXPERIENCE REQUIRED:
- 3-5 Years of experience working in regulated industry
SKILLS/ABILITIES:
- Excellent organizational skills, and ability to interact with cross functional teams throughout the organization
WORKING CONDITIONS
- Ability to lift 25LBs
SALARY RANGE
- $65,000 - $75,000 annually, plus bonus
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
