Job Description:- Job Description
- This position is responsible for performing inspections of incoming materials, coordinating themovement of staged materials, verifying staged materials, performing batch record inspections, and maintaining supplies and forms for packaging room use.
- POSITION REPORTS TO:Senior Manager, QualityPOSITION SUPERVISES:NoneESSENTIAL DUTIES AND RESPONSIBILITIESMaintain work area in accordance with cGMPs.
- Perform the incoming QC inspection of materials, including:o drug productso medical deviceso primary packaging componentso secondary packaging componentso label stocko clinical labels
- Verify materials pulled for staging into batch records.
- Assemble appropriate materials as specified in batch records.
- Perform room clearance inspections before staging materials into packaging rooms.
- Perform end of job inspections for batch records.
- 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 recordissues or questions about packaging activities.
- Perform end of job inspections of completed batch records.
- Clean and calibrate the bench scales and analytical balances, 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 GMPareas.
- 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).Assist with development of standard operating procedures (SOPs), data capture forms and otherassociated QA/QC documents.
- Revise documents in ZenQMS.Other duties as assigned.
MINIMUM QUALIFICATIONS: (KNOWLEDGE, SKILLS, AND ABILITIES)
High school diploma or equivalent work experience Excellent interpersonal skillsExcellent reading and writing skillsExcellent communication skills English literacy Excellent mathematical skills Computer literacy skills Attention to detail Strong understanding of GMPsEffective time management skills Experience working as a Xerimis packaging room supervisor Familiarity with the pharmaceutical industry
