Quality Assurance Inspector I

Blistex Inc; Oak Brook (IL); On-site; USD 29,000 - 33,000; Full time

Job summary

Blistex Inc. is hiring a Quality Assurance Inspector I for Oak Brook, IL. The role covers QA receipt and production inspections, sampling and confirming conformance of packaging, raw materials, and batch records.

It requires reading and following procedures, and acts as a liaison between Production and Quality. The position is hourly, 6 AM - 2:30 PM, with focus on documentation and regulatory compliance for OTC drug production.

Qualifications

• High School Diploma or GED required; additional education preferred.
• Minimum 2 years in a QA environment, cosmetics/pharmaceutical OTC preferred.
• Ability to read, review and follow procedures.
• Strong documentation and record-keeping skills.
• Good communication and cross-functional collaboration.

Responsibilities

• Evaluates receipts for conformance to purchase order requirements.
• Verifies integrity and labeling of shipping containers.
• Samples receipts based on a statistical sampling plan.
• Inspects items using scales, rulers, micrometers and calipers.
• Maintains files of receipt inspection and vendor performance reports.
• Performs transactions in Quality Systems receipt inspection process.
• Assists in development and maintenance of item specifications.
• Coordinates with Purchasing to set supplier standards.
• Reads, reviews and follows documents and procedures.
• Monitors line clearance functions.
• Issues production paperwork and labels.
• Draws and retains samples from production lines for testing.
• Acts as liaison between Production and Quality.
• Performs yearly monitoring of retain samples.
• Examines labeling before filling operation.
• Understands batch documentation and cGMP for OTC drugs.

Skills

QA receipt inspection

QA production inspection

Documentation review

Statistical sampling

Attention to detail

Education

High School Diploma or GED

Tools

QMS

Measuring tools

Job description

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Quality Assurance Inspector I

Regular Full-Time Oak Brook, IL, US

2 days ago Requisition ID: 1426

Salary Range: $21.32 To $24.00 Annually

Job Posting: Quality Assurance Inspector I

Location: Oak Brook, IL

Schedule: 6 AM - 2:30 PM

Status: Hourly, Non-Exempt

About the Role:

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.

Key Job Responsibilities

• Evaluates each receipt for conformance to purchase order requirements.
• Verifiestheintegrityofshippingcontainersandensuresthateachcontainerisproperlylabelled.
• Samples each receipt based upon a statistical samplingplan.
• Inspects sampled items, following established Company specifications, by using visual evaluations and measurement devices that can include scales, rulers, micrometers, and callipers.
• Maintains files of receipt inspection and vendor performancereports.
• PerformscomputertransactionsaccordingtotheQualitySystemsreceiptinspectionprocess.
• Assists in the development and maintenance of item specifications and masterfiles.
• Coordinates, in conjunction withthe Purchasing Department, the set-up of standards withsuppliers.
• 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.).

Basic Qualifications

• 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.

Additional Qualifications

• High School Diploma or GED required; additional education preferred.
• Theknowledgeandskillsrequiredforthispositionareacquiredwith a minimum of 2yearsofexperiencein aQuality 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.

Diverse Experiences

Blistex is committed to a diverse and inclusive workforce. Blistex is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age or any other legally protected status.

We’re continuously raising our performance bar as we strive to become the best in our industry. You will find endless knowledge-sharing, mentorship, career opportunities and development opportunities to help you become a better professional and/or leader.

Compensation

The base pay for this position ranges from $21.32 to $24.00. Pay is based on a number of factors including job related knowledge, skills and experience. The job role is eligible for a discretionary bonus that may be provided as part of a total compensation package.

As part of the total compensation package a full range of benefits are offered including medical coverage, insurance, and financial benefits. For more information, please visit https://blistexinc.com/employee-benefits/ .