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
Quality Assurance Inspector responsible for day to day in process quality checks across manufacturing lines to ensure all Finished Goods meet product specifications
ESSENTIAL FUNCTIONS AND BASIC DUTIES
- 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
PERFORMANCE MEASUREMENTS
- First time right on review of production jackets
- On-time completion of all training
QUALIFICATIONS
EDUCATION/CERTIFICATION:
- Bachelor's Degree or equivalent experience
REQUIRED KNOWLEDGE:
- Proficiency in Microsoft Office Suite
EXPERIENCE REQUIRED:
- 3+ Years of experience working in regulated industry
SKILLS/ABILITIES:
- Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization
WORKING CONDITIONS:
- Ability to lift 25 pounds
SALARY RANGE
- $40,000 - $60,000 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.
#LI-PDI
#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)