Quality Assurance (QA) Documentation Assistant

Date Posted: 12/26/2025

Hiring Organization: Rose International

Position Number: 494969

Industry: Biotech/Healthcare

Job Title: Quality Assurance (QA) Documentation Assistant

Job Location: Myerstown, PA, USA, 17067

Work Model: Onsite

Shift: M-F 7:00am Start

Employment Type: Temporary

FT/PT: Full-Time

Estimated Duration (In months): 12

Min Hourly Rate($): 26.00

Max Hourly Rate($): 36.00

Must Have Skills/Attributes: Audit, Document Review, SAP, SOP

Experience Desired: document review or auditing experience in a cGMP environment (5 yrs); Experience using SAP, MES, or similar automated inventory systems (5 yrs)

Required Minimum Education: High School Diploma or equivalent

**C2C is not available**

Job Description

• Drug screen & criminal background check will be required
  
  

Position Summary

The Quality Assurance (QA) Documentation Assistant supports quality assurance documentation and release activities within a GMP-regulated manufacturing environment. This role is responsible for auditing manufacturing and packaging records, ensuring compliance with cGMPs, SOPs, and plant quality standards, and supporting timely production release.

Required Qualifications

• High School diploma or GED with at least 5 years of document review or auditing experience in a cGMP environment
• Strong PC skills; proficiency with Microsoft Office
• Experience using SAP, MES, or similar automated inventory systems
• Demonstrated ability to interpret records, perform accurate calculations, and maintain organized documentation
• Strong communication and interpersonal skills
• Ability to lift 50 lbs
  
  

Responsibilities

• Audit manufacturing and packaging documentation for GMP and quality compliance
• Review batch manufacturing and packaging records for accuracy, completeness, and calculations
• Assign material disposition and support release of intermediates and packaging components
• Issue and reconcile manufacturing, packaging, and QC laboratory documentation
• Write, revise, and maintain SOPs within area of responsibility
• Support document control, filing, and maintenance of batch record archives
• Coordinate priorities with documentation auditors, production, QA, and supply chain teams
• Maintain quality databases, reports, and release tracking tools
• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
  
  

Benefits

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).