Quality Assurance Associate, Batch Record Inspector

Position Description

Position Summary

This position is responsible for coordinating the movement of staged materials and verifying staged materials, performing batch record inspections, and maintaining supplies and forms for packaging room use.

Position Reports to

QA Manager, Batch Record Inspection

Position Supervises

None

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

  • Maintain work area in accordance with GMPs
  • Verify materials pulled for staging into batch records
  • Assemble appropriate materials as specified in batch records
  • Perform room clearance inspections before staging of materials into packaging rooms
  • 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 log books to verify cleans and proper entries
  • Verify materials pulled for interoffice request shipments
  • Enter and verify data in the Inventory Control System (ICS)
  • Create and 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
  • Excellent problem solving/investigational skills
  • Excellent mathematical skills
  • English literacy
  • Computer literacy skills
  • Attention to detail
  • Strong understanding of GMPs
  • Effective time management skills
  • Familiarity with the pharmaceutical industry
  • Previous successful Packaging Room Supervisor experience

 

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.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds.  Specific vision abilities required for this job include close vision, color vision, and ability to adjust focus.  While performing the duties of this job, the employee is regularly required to talk or hear.  While performing the duties of this job, the employee is exposed to warehouse 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.

 

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