This position is responsible for performing inspections of incoming materials, coordinating the
movement of staged materials, verifying staged materials, performing batch record inspections,
and maintaining supplies and forms for packaging room use.
POSITION REPORTS TO:
Senior Manager, Quality
POSITION SUPERVISES:
None
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Maintain work area in accordance with cGMPs.
- Perform the incoming QC inspection of materials, including:
o drug products
o medical devices
o primary packaging components
o secondary packaging components
o label stock
o 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 record
- issues 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 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).
- Assist with development of standard operating procedures (SOPs), data capture forms and other
- associated 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 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
