QA Inspector

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.

Essential 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.

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, subtraction, division, multiplication, and percentages.

Reasoning Ability

The QA Line Inspector must be able to analyze and interpret data relating to various projects and report issues and problems that arise. The QA Line Inspector must be able to:

• 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

Physical Demands and Work Environment The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential job functions.

• 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.