Quality Control Associate - Batch Record Inspector

Position Summary

This position is responsible for performing batch record inspections, verifying staged materials, physically staging materials intended for packaging, and maintaining supplies and forms for packaging room use.

Essential Duties and Responsibilities

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

· Maintain work area in accordance with GMPs

· Verify materials selected 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

· Remove and store finished goods after completion of the batch record

· Perform ongoing inspections of batch record activities to verify that special instructions and Xerimis SOPs are being followed

· Follow Batch Record Special Instructions and perform QC steps as stated

· Provide comprehensive guidance to packaging room personnel regarding quality concerns

· 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

· Cross-functional training within other QA areas to support operational flexibility

Minimum Qualifications (Knowledge, Skills, and Abilities)

• High school diploma or equivalent work experience
• Excellent interpersonal skills
• Excellent English reading and writing skills
• Excellent English communication skills
• Excellent problem solving/investigational skills
• Excellent mathematical skills
• Fluent in English
• English literacy
• Computer literacy skills
• Attention to detail
• Strong understanding of GMPs
• Effective time management skills
• Familiarity with the pharmaceutical industry
• Quality Assurance/Control Experience
• Previous Quality Inspector Experience

Job Type: Full-time

Pay: $22.00 - $25.00 per hour

Work Location: In person

Salary : $22 - $25