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QA InspectorPureTek • San Fernando, California, United States
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QA Inspector

PureTek
  • US
    San Fernando, California, United States
  • US
    San Fernando, California, United States
Jetzt Bewerben

Über

QA Inspector 4 days ago Requisition ID: 1042
Salary Range: $22.00 To $23.00 Hourly
Summary The Quality Assurance Line Inspector works under the general direction of the QA Manager and is responsible for the assigned day‑to‑day functions within the Quality Assurance department. Ensuring compliance with current Good Manufacturing Procedures (cGMPs), the company’s Standard Operating Procedures (SOPs), and regulatory guidelines; preparing management reports as requested. Uses discretion to make independent decisions, applying knowledge of industry best practices, cGMPs and SOPs, and regulatory requirements.
Essential Responsibilities
Inspect and issue reports of all packaging finished goods using established protocols: audits item number versus description, inspects against standards, creates standards for approval as needed, submits samples to the laboratories as required for product approval.
Check and inspect the quality of the filled product during the in‑process and compare against the standard.
Check quality, height, and weight of bottles and crimp of tubes, and check the bar code.
Maintain a log book.
Apply release stickers on pallets of finished goods.
Prepare daily reports of in‑process packaging products.
Imprint quarantine stickers and place them on the pallets.
Estimate the yield of the batches as per protocols and close the reports.
Support other areas of the department: audits batch records, processing checks for uniformity, filling, line inspection, special orders.
Maintain cleanliness and good housekeeping in work area including tools used.
Assist in physical inventory counts as requested.
Perform other duties assigned by the supervisor.
Review and finalize batch records.
Release batches for shipment.
Process Questionable Material Reports (QMR), Material Destruction Records (MDR), and Reprocessing Orders (RO) as needed.
Review and approve SOPs and other QA‑related documents.
Conduct internal audits and participate in client and regulatory agency audits.
Maintain appropriate QA records and documentation.
Consistently demonstrate excellent interpersonal skills and professionalism to company management, all levels of staff and vendors, and outside agencies.
Adhere to company policies and procedures and set a positive example for others within the organization.
Establish priorities to ensure timely job completion.
Supervisory Responsibilities This position has no direct supervisory responsibilities.
Qualifications
Discretion in handling confidential and sensitive matters.
Knowledge of drug cGMPs, SOPs, and regulatory guidelines including FDA requirements.
Knowledge of QA industry best practices.
Education, Experience, and Licensure High school diploma required and 2+ years of experience inspecting pharmaceutical, cosmetic, or nutraceutical products in a GMP environment.
Technical Skills
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
Language Skills Must be able to clearly and concisely communicate verbally and in writing in English. Must be able to present information in front of groups clearly and concisely.
Mathematical Skills Must be able to analyze and present quantitative data. Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.
Reasoning Ability
Exercise appropriate judgment to escalates issues to the QA Lead, Supervisor, or senior management.
Focus on work assignments to ensure goals and timelines are met.
Apply knowledge of Quality Assurance best practices, Company policies, and cGMPs in the manufacturing area.
Physical Demands and Work Environment
Work will be conducted in a standard manufacturing environment at the production lines with associated distractions including talking, paging systems, and noise from the machinery and equipment including horns and bells.
Temperatures are regulated by facilities management. Temperatures in the warehouse and production areas may be extremely hot or cold and not within the control of the individual.
Must be able to stand for up to eight hours per day, walk for up to eight hours per day, lift and carry up to 20 lbs. with or without assistance, reach above shoulder height or below knees, twist, bend, stoop, kneel and crawl to retrieve or inspect items at ground or floor level.
Must be able to perform repetitive tasks for up to eight hours per day including making boxes, inserting and twisting lids and caps, filling boxes with products, applying labels, and emptying containers.
Manual dexterity is required to handle small parts.
Must be able to wear gloves, head covers, beard covers, masks, goggles, and other safety equipment.
Must be able to perform repetitive motions including those requiring manual dexterity to insert bottle caps, lids, pumps, twist or push/snap them closed, lift small items, and place them on the line or in a box for up to eight hours per day.
Exposure to standard chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs.
Weekly rotating shift between 1st shift and 2nd shift.
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  • San Fernando, California, United States

Sprachkenntnisse

  • English
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