Quality Assurance Inspector -1st Shift

Summary / objective
The Quality Assurance Inspector is responsible for performing day-to-day activities of the Quality Assurance Inspection group.  The Quality Assurance Inspectors will perform Quality in-process product checks/testing as required; verify manufacturing and packaging activities are performed as outlined in the respective records; performs the initial review and verification of manufacturing and packaging records, equipment and room logbooks are accurately completed by operations, maintenance, and engineering personnel in real time.

 

Essential functions

• Adhere to all company policies and Human Resource procedures.
• Adhere with SOPs and regulatory requirements such as GMPs, GDPs, and OSHA regulations.
• May be required to certify to work with Controlled Substances.
• Ability to communicate with QA department leadership and production members on production activities.
• Immediately inform the Quality Assurance (QA) Lead, Quality Assurance (QA) – Supervisor, and Operations/Production Supervisor of all:

• Failing Quality Inspection results
• Malfunctions of all production and packaging equipment
• Contamination of product including but not limited to human contact, bio-hazard contamination, foreign material (i.e., foreign capsule or tablet found), equipment lubricants, dust, debris, etc.

• Ensure timely and accurate inspection of production activities including but not limited to:
  • Room Clearance Checks and activities
  • Clean Room Checks and activities
  • Product and Weigh Checks and activities
  • All AQL and In-Process inspections including pH and Density as required.
  • Equipment Checks and activities
  • Review and approve executed batch records, Forms, and logbooks.
  • Remain current with all required training.
  • Review and verify all labels issued to production and packaging batch records.
• Ensure job tasks as assigned are completed and executed with a high level of Quality.
• Performs other tasks as assigned.

Work environment

This job operates in a pharmaceutical cGMP manufacturing environment.  Staff must adhere to all SOP gowning requirements and will routinely wear a lab coat, steel toe shoes, and any additional and appropriate Personal Protective Equipment (PPE) as required.  This role requires Good Hygiene and facial hair must be neat and tight and kept well-trimmed to prevent incidental contamination of product.  Working with Biohazardous and Controlled Substance materials may be required.

Physical demands

The employee will be required to stand for long periods of time.  Specific vision abilities are required by this position.   This job requires the need to be able to lift ups to twenty-five (25) pounds.

Position type/expected hours of work
This is a full-time position which operates on a two-shifts platform.  Core work hours for 1st Shift are Monday through Friday, 6 a.m. to 2:30 p.m.  Extended work times (earlier or later) or weekend work is routinely required.  Flexibility to work various shifts is highly desired.

 

Required education and experience

• High School Diploma or equivalent.
• Ability to read and interpret instructions.
• Six (6) months to 12 months of experience in Quality Control inspections a pharmaceutical cGMP manufacturing environment.

Preferred education and experience

• Associates Degree in relevant field or equivalent military or industrial training in Quality inspections.
• 1-2 years of experience in Quality Control inspections a pharmaceutical cGMP manufacturing environment.
• Excellent interpersonal communication
• Qualified to work with controlled substances may be required

 

Work authorization/security clearance (if applicable)

• Authorized to work in United States