Quality Assurance Inspector I

Blistex Inc•Oak Brook, IL

10d•$21 - $22

About The Position

The Quality Assurance Inspector I can have responsibilities in two areas: QA Receipt Inspection and QA Production Inspection. The position is responsible for sampling and inspecting incoming packaging and chemical raw materials for conformance to regulatory and Company standards. He/she ensures that everything required to complete a designated batch (raw materials, components, caps, bottles, and the packaging) is correct. The position is also responsible for the issuing of batch records and monitoring the quality of production.

Requirements

High School Diploma or GED required; additional education preferred.
The knowledge and skills required for this position are acquired with a minimum of 2 years of experience in a Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry.
Computer literacy and experience.
Ability to multi-task and maintain precise organization in a fast-paced environment.
Ability to follow routine process without deviation.
Good listening skills to assure mutual understanding.
Can assume responsibility for actions and able to work independently and meet deadlines on a multitude of tasks.
Ability to read, review and compare documents and follow procedures.
Ability to prepare detailed and accurate documentation.
Ability to understand vendor documentation for components shelf-life.
Ability to support projects as assigned.
Ability to perform basic arithmetic and complete 2-D measurements.
Effective interpersonal skills are required to interact with various levels of internal and external customers.
Ability to work independently and meet deadlines on a multitude of tasks.
Good organizational ability.
High degree of familiarity with and ability to use office machines.
Must be discreet with confidential information of which he/she has access.
Capable of listening actively and readily assumes responsibility for actions. Able to act as liaison between Production and Quality departments.
Solid understating of Batch documentation requirements and all associated production and compliance steps.
Ability to understand and review all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, etc.)
Mastered the ability to prepare detailed and accurate documentation and able to proficiently search and issue documents via the organization QMS.
A firm understanding of general quality assurance practices and principles and cGMP requirements associated with the roles and with the production and Quality life cycle of an OTC drug.
Ability to understand "deals" and "PO" relationships associated with various markets.
Ability to understand the organization Stability program and sample retaining program.
Ability to accept other duties and projects as assigned.
Ability to execute projects under supervision.
Ability to understand and to perform calculations and measurements as required in SOPs.
Ability to understand the company nonconformance SOPs and assist with performing the investigations.
Understand Quality requirements and able to identify deficiencies during the product production process.
Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management and comply with Company policies.

Responsibilities

Evaluates each receipt for conformance to purchase order requirements.
Verifies the integrity of shipping containers and ensures that each container is properly labelled.
Samples each receipt based upon a statistical sampling plan.
Inspects sampled items, following established Company specifications, by using visual evaluations and measurement devices that can include scales, rulers, micrometers, and callipers.
Document activities performed.
Maintains files of receipt inspection and vendor performance reports.
Performs computer transactions according to the Quality Systems receipt inspection process.
Assists in the development and maintenance of item specifications and master files.
Coordinates, in conjunction with the Purchasing Department, the set-up of standards with suppliers.
Ability to read, review and compare documents and follow procedures.
Monitors line clearance functions.
Issue production paperwork and issues labels.
Draws and keeps records of samples from production lines for testing, retention, stability, and other purposes, as required or as necessary.
Acts as liaison between the Production and the Quality Department.
Performs yearly monitoring of retain samples.
Examines filling/packaging labelling before filling operation.
Master the ability to read, review and compare documents and follow procedures.
Solid understating of Batch documentation requirements and all associated production and compliance steps.
Ability to understand and review all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labelling, production sampling requirements, and etc.).
Quarantine filling/packaging materials, brought to the production lines, if not in conformance with standard specifications/artwork or are found defective.
Quarantines finished products if found defective due to labelling, weight deficiencies, coding, etc.
Prepares “REJECT” stickers, if needed, for rejected filling/packaging materials, from the production lines.
Assists Manager, Quality Assurance with Auditing Program.
Assists with APR review.
Organizes and maintains samples of retain room within the retain room.
Performs and assumes duties and responsibilities, as may be required by the Senior Manager, Quality Assurance.