Associate III, QA Inspector

Description

To ensure the quality and compliance of final packaged product, back-up raw material release specialist with release of non-animal origin ingredient raw materials and the inspection of the labels.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees.

Duties & Responsibilities

Packaging Department Support and Packaged Product Inspection and Release

Perform packaging component issuance verification

Conduct product inspection to ensure:

Verification of expiration date and serial number applied to label

Verification of correct version of label applied to product.

Packaging documentation review and release

Verification of approval of release by USDA, CVB-IC

Verification of inventory at release

Perform system transactions in Oracle for the final release of product

Perform line clearances of packaging equipment

Conduct self-inspection audits (process, facility and documentation

Back up Raw Material Release Specialist with Label Inspection

Inspect and release controlled labeling, including flat-cut, folding carton, and pressure-sensitive labeling in accordance with 9CFR 112.5(g) and applicable Quality Assurance procedures

Ensure inventory of controlled labeling is in controlled storage and ensures Packaging Label Cage technicians accurately accounts for inventory at all times in accordance

Ensure compliance with 9CFR 112.1 through strict adherences to applicable Quality Assurance procedures

Ensure an Inspection-ready label cage, in accordance with VSM 800.91, section J. “Labels”

Assist with the label depletion process in a timely manner to ensure only current, approved labels are available for use

Perform status changes – including release and rejection – in Oracle to disposition lots of incoming labels

Back-up Raw Material Release Specialist with non animal origin ingredient Raw Material Inspection as needed

Perform incoming receipt on raw materials including the following:

Review of reception documents against specification to ensure proper part number received

Physical inspection of raw materials to ensure compliance with specified description

Review of CofA, CofI, CofO, etc. to ensure compliance with specifications

Perform status changes – including release and rejection – in Oracle to disposition lots of incoming raw materials

Ensures routine packaging activities aligns with regulatory compliance for USDA, FDA and other authorities, as applicable.

Requirements

High School Diploma or Associate’s Degree from an accredited institution

Five-plus (5) years of experience related to product or raw material inspection required

Must have a good understanding of QA related to vaccine packaging process; Examples include: finished goods product release, batch record review, and specification review.

Computer skills preferred

Strong focus on attention to details

Desired Skills, Experience and Abilities

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.