QA Inspector

Puretek Corporation•San Fernando, CA

7d•$22 - $24•Onsite

About The Position

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.

Requirements

Discretion in handling confidential and sensitive matters.
Knowledge of drug cGMPs, SOPs, and regulatory guidelines including FDA requirements.
Knowledge of QA industry best practices.
High school diploma required and 2+ years of experience inspecting pharmaceutical, cosmetic, or nutriceutical products in a GMP environment.
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
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.
Must be able to analyze and present quantitative data.
Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.
The QA Line Inspector must be able to analyze and interpret data relating to various projects and report issues and problems that arise.
Exercise appropriate judgment to escalate 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.

Responsibilities

Inspects 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.
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.
Maintains retain Log Book.
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.