Quality Inspector 3rd Shift

Quality Seymour, Indiana


Description


Summary:

The Quality Inspector supports manufacturing and packaging for quality related incidents and ongoing cGMP compliance.
Quality Inspectors are required to make decisions regarding product quality in order to isolate, segregate, and correct potential impact to manufacturing and packaging in a timely manner in order to prevent loss of product integrity and operations downtime.
Backup of manufacturing team leads and supervisors for appropriate batch record steps.
Verification of cleanliness of equipment.
Release of equipment for use.
Isolation and evaluation of suspect product.
Live review of batch records for completeness and compliance.
Continuous auditing of the facility for cGMP compliance.
Issuance of cGMP documentation on off-shifts

Responsibilities: 

  • Respond to quality incidents such as OOS in-process results, foreign materials, spills, equipment failure etc.
  • Isolate impacted product.
  • Determine next course of action for continuation of production.
  • Communicate and document actions taken.
  • Review live batch records for completeness and compliance.
  • Audit of the facility for ongoing cGMP compliance.
  • Backup operations supervisors and team leads.
  • Release equipment for use.
  •  Verify cleanliness of equipment.
  • Issue supplemental cGMP documentation.
  • Training for inspection activities.
  • Issuance and management of supplemental inspection system.
  • Gather data for quality assessors and management.
  • Gather data for triage processes.
  • Participate in triage.
  • Identify and update SOP discrepancies as continuous improvement.
Education and Experience:

Required - High School Diploma/GED: Preferred - Associate's Degree
Two years of experience in the pharmaceutical industry and knowledge of cGMP is necessary.
Experience in the areas of production, packaging, or validation or an equivalent education in a science related discipline is required

Specific Skills:

• Demonstrated ability to prioritize, organize and work effectively.
• Strong observational skills and attention to detail are required.
• Strong communication skills (both oral and written) for internal contacts are required.
• Strong follow-up skills and the ability to provide timely closure of assigned tasks.
• Strong technical writing and problem solving skills. Experience in reviewing scientific documents/reports to assure compliance.
• Strong computer skills are required. Proficiency in the following are desired: Microsoft Word, Microsoft Excel and Microsoft Access.
• Strong interpersonal skills with the ability to achieve consensus and cooperation with varying departments and personalities.

Physical Requirements:

• Personnel are expected to walk throughout the facility up to 90% of the time on shift.
• Personnel may be required to lift up to 50 pounds.





.