Description
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
The Lead Quality Assurance Inspector will be responsible for day to day in process quality checks across manufacturing lines to ensure all Finished Goods meet product specifications. Lead QA Inspector will also assign and balance work across 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:
- Associates Degree or equivalent relevant experience
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
SALARY RANGE
- $65,000 to $75,000 annually
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
- Medical, behavioral & prescription drug coverage
- Health Savings Account (HSA)
- Dental
- Vision
- 401(k) savings plan with company match and profit sharing
- Basic and supplemental Life and AD&D insurance
- Flexible Spending Accounts (FSAs)
- Short & long-term disability
- Employee Assistance Program (EAP)
- Health Advocacy Program
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
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#LI-ONSITE
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)