QA Operations Associate I- 2nd Shift

Nature and Scope

This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.

Essential Duties And Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification
• Conduct accurate verifications and checks as well as accurate process inspections
• Conduct accurate packaging AQL inspections
• Identify out of specification product, ensuring segregation and escalation, as required
• Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements
• Conduct component and raw material release
• Conduct chart monitoring, ensuring escalation, as required
• Support product shipping activities and perform quality related oversight and verifications
• Generate logbooks and sheets/labels
• Review Bills of Materials

Education Requirements And Qualifications

• High School Diploma or GED equivalent required
• Associates or Bachelor’s Degree preferred
• Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred

Physical Environment And Requirements

• Possess physical ability to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
• PPE and Respirators are essential for the health and safety of employees
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision
• Maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
• Employee must be able to occasionally lift and/or move up to 25 pounds

Skills

• Intermediate skills in Microsoft Word and Excel
• Excellent organizational, interpersonal and communication skills (written and oral)
• Ability to take feedback constructively and function in a team oriented work environment

Benefits

Equal Opportunity Employer

Pay

Commensurate with experience

Schedule

TBD