Role & seniority: Quality Assurance (QA) Inspector, entry to mid level in manufacturing/QMS environments.

Stack/tools: JD Edwards (transactions), batch records/logs/forms, QA Alerts system; sampling instruments for swab/Rodac; general documentation tools; basic computer skills.

Top 3 responsibilities

Inspect, approve, and authorize rooms, lines, equipment, and components for in-process and finished product use.
Sample, inspect, test, and document in-process items and finished products; ensure cGMP, FDA/DEA regulatory compliance; issue QA Alerts for deviations.
Review records for accuracy/thoroughness; monitor manufacturing areas for SOP/cGMP compliance; inform management of problems and deviations.

Must-have skills

High school diploma or equivalent; basic math and computer skills; ability to read/write and follow English instructions.
Attention to detail; ability to document thoroughly; ability to work within regulatory and internal procedures.
Able to operate in a manufacturing plant environment and handle routine sampling/tests.

Nice-to-haves

Experience with QA in FDA/DEA-regulated manufacturing; familiarity with batch records and deviation handling; experience with JD Edwards or similar ERP systems.

Location & work type: Manufacturing plant environment; ability to work second/third shifts and weekends as required; potential exposure to moving parts, chemicals, noise; physical demands include standing, lifting up to 50 pounds.

Full Description

Overview Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures. Responsibilities Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel. Approve components for in-process operations. Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations. Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance. Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments. Review records for cGMP compliance for accuracy and thoroughness. Inform management of problems, failures and deviations from established internal and regulatory standards. Apply disposition sticker to components and in-process materials. Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage. Perform swab and Rodac Plate sampling as required. Perform transactions in JD Edwards when required. Qualifications

Competencies

Education / Experience

High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required.

Judgment / Decision Making

Duties performed within a framework of departmental or functional protocol requiring a minimal degree of original thinking.

Work Environment

Majority of time spent at manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury. May handle or work with laminates and units containing a Class II Controlled Substance.
Ability to work second and third shift, if required. Ability to work Saturday and/or Sunday, if required.

Physical Demands

Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer.

QA Inspector - TEMP