Role & seniority: Quality Assurance Technician (entry-level) focused on QA tasks in manufacturing.

Stack/tools: JD Edwards system; batch records, forms and logs; sampling equipment and procedures (swab/Rodac), in-process and finished goods testing; adherence to SOPs, cGMPs, FDA/DEA regulations.

Top 3 responsibilities

Inspect and approve rooms, lines, equipment, and components for use; monitor manufacturing areas for compliance.
Sample, test, and document in-process items and finished products; process and distribute samples; maintain accurate batch records.
Review records for cGMP compliance; inform management of issues/deviations; issue QA Alerts for questionable materials or products.

Must-have skills

High school diploma or equivalent; basic computer and math skills.
Ability to read, write, and follow instructions in English.
Attention to detail and accuracy; ability to document thoroughly; able to stand for extended periods and lift up to ~50 lbs.
Flexibility to work second/third shifts and weekends if required.

Nice-to-haves

Experience with JD Edwards or similar ERP systems.
Familiarity with cGMP, FDA and DEA regulations and QA processes.
Prior QA/testing or manufacturing exposure; knowledge of sampling procedures and QA alert processes.

Location & work type: Primarily on-site at manufacturing plants; potential for second/third shift and weekend work as needed.

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