QA Inspector

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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; and preparing management reports as requested. Uses discretion to make independent decisions, applying knowledge of industry best practices, cGMPs and SOPs, and regulatory requirements.

Inspects and issue reports of all packaging finished goods using established protocols:

• Inspects against standards.
• Creates standards for approval as needed.
• Submits samples to the laboratories as required for product approval.

Checks and inspects the quality of the filled product during the in-process and compares against the standard.

Checks the quality, height, and weight, of the bottles and crimp of the tubes.

Checks the bar code.

Applies release stickers on pallets of finished goods.

Prepares daily reports of in-process packaging products.

Imprint quarantine stickers and place them on the pallets.

Estimates the yield of the batches as per protocols and closes the reports.

Supports other areas of the department:

• Audits batch records
• Processing checks for uniformity
• Filling
• Line inspection
• Special orders

Maintains cleanliness and good housekeeping in work area including tools used.

Assists in physical inventory counts as requested.

Perform other duties assigned by the supervisor.

Reviews and finalizes batch records.

Releases batches for shipment

Processes Questionable Material Reports (QMR), Material Destruction Records (MDR), and Reprocessing Orders (RO) as needed.

Reviews and approves SOPs and other QA-related documents.

Conducts internal audits and participates in client and regulatory agency audits.

Maintains appropriate QA records and documentation.

Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors, and outside agencies.

Adheres to company policies and procedures and sets a positive example for others within the organization.

Establishes priorities to ensure timely job completion.

Supervisory Responsibilities

This position has no direct supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 nutriceutical 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 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,…