IPQA Floor Inspector

JOB SUMMARY

•   Must complete all proper training forms for the applicable responsibilities listed below and contained within the position’s specific syllabus.

•  Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals.

•  Be able to perform all IPQA (In-Process Quality Assurance) functions.

•  Be able to perform incoming and outgoing inspections of finished product batches.

•  Have 2-3 year experience in required in-process checks/verifications for both manufacturing and packaging

•  Be able to work the shift hours (including overtime and weekends) as needed per production requirements

• Perform verifications using special instruments (Caliper, Balance, etc) to assign final Approval to Labeling, Packaging and Raw Materials.

REPORTING RELATIONSHIPS

This position reports the Supervisor

DUTIES & ESSENTIAL JOB FUNCTIONS

DUTIES & ESSENTIAL JOB FUNCTINS

PERCENT OF TIME

(Time of all duties must add up to 100%)

FREQUENCY

(daily, weekly, monthly, quarterly, yearly)

ESSENTIAL DUTIES (List in order of importance – most significant first)

75 %

Daily

Perform all required in-process testing & sampling of batches in progress and products to be packaged.

10 %

Daily

Verify and confirm issuances and reconciliation of product and components.

20%

Monthly

Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.

5%

Weekly

Complete all applicable training forms in a timely manner and forward to document control for archival

10%

Daily

Performing Cleaning Verification/Validation Swabbing of Equipment

5%

Weekly

Handle various requests from departments for developmental or investigative reasons

15%

Weekly

Data Entry of Finished Product Information into the APR (Annual Product Review ) system

5%

Weekly

Capture critical information for Customer Complaint investigations (when necessary)              

5%

Weekly

Review and Approve Preventive Maintenance or Work Orders; (in absence of Team Lead or Supervisor only)

5%

Daily

Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition

 

OTHER FUNCTIONS AND RESPONSIBILITIES

• Collection and inventorying of Retain and/ or Stability Samples
• Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)

• Replace Temperature/Humidity Charts weekly
• Participate in Stability/Validation product Sampling
• Maintaining IPQA supply inventory
• Perform other duties as assigned

QUALIFICATIONS

• Have 2-3years experience in both the Manufacturing and Packaging of Pharmaceuticals
• Experienced in proper documentation and correction practices

 

REQUIRED

•   Must be able to read, write and speak fluently in English

•  Ability to effectively communicate orally and in writing

•  Be able to work long hours to support production requirements

•  Be available for overtime including weekends

•  Be experienced in a pharmaceutical manufacturing/packaging environment

•  Possess the ability to analyze information and make consistently good decisions

 

ANY REQUIRED LICENSES/CERTIFICATIONS

• A familiarity with cGMPS, CFRs, OSHA and FDA regulations
• Experience with deviations /incidents and CAPA
• Forklift (Stand-up) experience

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

• Stand/walk for the majority of the shift.
• Must be able to bend at the waist and knees as well as twist at the trunk.
• Must practice good personal hygiene
• Must be able to lift up to 30 lbs.