QA Operations Associate I - New Albany, OH

VetJobs; New Albany (OH); On-site; USD 42,000 - 62,000; Full time

Job summary

American Regent in New Albany, OH is seeking a Quality Assurance Technician to ensure GMP-compliant operations on the packaging line and in inspection areas. The role includes verifications, material release, logbook management, and collaboration with shipping activities.

The position requires a High School Diploma or GED, with preference for Associates or Bachelors degrees and at least 1 year in a FDA-regulated environment. On-site work with potential overtime.

Qualifications

• High School Diploma or GED required; Associates/Bachelors preferred.
• Minimum 1 year experience in FDA regulated environment preferred.
• Ability to work independently; strong organizational and communication skills.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as process inspections.
• Conduct accurate packaging AQL inspections.
• Identify out of specification product, escalating as required.
• Resolve errors per SOPs and company policies; ensure cGMP compliance.
• Perform component and raw material release.
• Maintain room, area and equipment clearances.
• Review Bills of Materials.
• Participate in Media Fill and maintain qualification.
• Generate logbooks and labels; support product shipping activities.
• Perform any other tasks/duties as assigned by management.

Skills

Attention to detail

Interpersonal skills

Strong communication

Education

High School/GED

Associates or Bachelor's degree preferred

Tools

Microsoft Word

Excel

Job description

Job Description

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. ATTENTION MILITARY AFFILIATED JOB SEEKERS.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• 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
• Basic knowledge of cGMPs and supporting regulatory documents
• Achieve and maintain clean side gown and sterile side gown qualifications
• Achieve and maintain Class A qualification
• Perform room, area and equipment clearances.
• Participate in Media Fill and maintain qualification
• Able to perform tasks with minimal error rate.
• Perform any other tasks/duties as assigned by management.

Auto req ID

482104BR

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.
• Must be able to do work independently.
• Intermediate Skills In Microsoft Word And Excel Are Required.
• Excellent organizational, interpersonal and communication skills (written and oral) required.
• Ability to take feedback constructively and function in a team oriented work environment.
• Ability to work overtime as needed.

Physical Environment and Requirements

Physically able 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.

Employees must 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.

Location and Identification

• City* New Albany
• State* Ohio
• Job_Category Operations
• Job Code Manufacturing Manufacturing
• Affiliate Sponsor American Regent