Quality Control Associate, Batch Record and Incoming Goods Inspector

Quality Control Associate, Batch Record and Incoming Goods Inspector

XERIMIS, INC - 2.8

Moorestown, NJ Job Details Full-time $23 - $28 an hour 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Qualifications Computer operation Computer literacy Writing skills Basic math English High school diploma or GED Attention to detail Time management Full Job Description Position Summary This position is responsible for completing the inspection of all incoming materials and for tasks and responsibilities listed below to coordinate the movement of staged material materials, perform batch record inspections, and maintaining supplies and forms for packaging room use.

Position Reports to:

Senior Manager, QA Position Supervises:

None Essential Duties and Responsibilities The essential functions include, but are not limited to the following: Maintain work area in accordance with cGMPs. Perform the incoming QC inspection of materials, including: drug products medical devices primary packaging components secondary packaging components label stock clinical labels Verify materials pulled for staging into batch records. Perform room clearance inspections before staging materials into packaging rooms. Perform end of job inspections for batch records. Assist with development of standard operating procedures (SOPs), data capture forms and other associated QA/QC documents. Physically stage materials for batch records. Perform ongoing inspections of batch record activities to verify that special instructions and Xerimis SOPs are being followed. Respond to any requests, comments, or questions from packaging room personnel. Liaise between packaging room personnel and project managers regarding any batch record issues or questions about packaging activities. Perform end of job inspections of completed batch records. Clean and calibrate the bench scales, as needed. Replenish QC-issued forms for use in packaging rooms. Replenish Supervisor-issued forms for use in packaging rooms. Replenish cleaning supplies (i.e., Micro 90, deionized water, isopropyl alcohol) for use in GMP areas. Maintain organization of all retention samples. Execute weekly reviews of all logbooks to verify cleans and proper entries. Verify materials pulled for interoffice request shipments. Enter and verify data in the Inventory Control System (ICS). Revise documents in ZenQMS. Other duties as assigned. Minimum Qualifications (Knowledge, Skills, and Abilities) High school diploma or equivalent work experience Excellent interpersonal skills Excellent reading and writing skills Excellent communication skills English literacy Excellent mathematical skills Computer literacy skills Attention to detail Strong understanding of GMPs Effective time management skills Experience working as a Xerimis packaging room supervisor Familiarity with the pharmaceutical industry Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is required to sit; stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. While performing the duties of this job, the employee is exposed to warehouse areas, refrigerated (40°F/4°C) & frozen (-4°F/-20°C) conditions and operations (packaging) environments including regular exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate. Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship. The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Job Type:

Full-time Pay:

$23.00 - $28.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person