Overview
On Site
USD 30.00 per hour
Full Time
Skills
Recruiting
Health Care
Document Review
Microsoft Technologies
SAP
Inventory
Communication
Leadership
Good Manufacturing Practice
Organizational Skills
Standard Operating Procedure
Inspection
Regulatory Compliance
GMP
MES
Auditing
Quality Control
Document Management
Documentation
Testing
Work In Process
Supply Chain Management
Database
Quality Assurance
Manufacturing
Storage
Job Details
Date Posted: 08/19/2025
Hiring Organization: Rose International
Position Number: 487193
Industry: Biotech/Healthcare
Job Title: QA Documentation Assistant
Job Location: Myerstown, PA, USA, 17067
Work Model: Onsite
Shift: M-F start 7:00am
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 6
Min Hourly Rate($): 30.00
Max Hourly Rate($): 36.00
Must Have Skills/Attributes: Audit, Document Control Procedures, Document Review, GMP, SAP
Experience Desired: Experience in document review/auditing role in a cGMP industry (5 yrs); Experience using SAP, MES, or other automated inventory system (1 yrs)
Required Minimum Education: High School Diploma or equivalent
**C2C is not available**
Job Description
***Drug screen & criminal background check will be required
EDUCATION / EXPERIENCE REQUIREMENTS
High School degree or GED with at least 5 years of experience in document review/auditing role in a cGMP industry is required.
College background and/or secretarial or administrative certifications a plus.
REQUIRED SKILLS
Strong Personal Computer skills required; Microsoft software preferred.
Previous experience using SAP, MES, or other automated inventory system is required.
Must have excellent interpersonal skills, written and oral communication skills, and have demonstrated ability to work effectively in a team environment.
Must have demonstrated leadership skills in audit/review of cGMP documentation & in various special projects.
Must have demonstrated ability to have good interpretive judgment of records, accurate mathematical calculation skills, organizational skills, and legible handwriting is required.
Physically able to lift up to 50 pounds.
POSITION SUMMARY
In QA Doc/Release, performs usage decisions on inspection lots of packaging components, and intermediates as to conformance to current good manufacturing practices (cGMPs), standard operating procedures (SOPs), and plant quality standards. Review in-process records and quality assurance test results for compliance with specifications and assign disposition. Review and assign expiry dating to process inspection sheets used for finished goods packaging.
RESPONSIBILITIES
Audit all manufacturing and packaging documentation to ensure compliance with all GMP regulations and Bayer standards. Release bulk intermediates and package component materials to ensure timely release to meet production requirements.
Coordinate priorities with Documentation Auditors to ensure top priority work is accomplished in timely fashion.
Review production records (i.e. batch manufacturing, packaging records and MES production reports) for accuracy and completeness; perform mathematical audit of calculations; prepare and maintain batch jackets.
Issue/Reconcile manufacturing and packaging documents for execution according to SOPs in timely manner to support production schedules.
Issue/Reconcile QC laboratory documentation for execution according to SOPs.
Support site practices for document control in issuance/reconciliation of working documents.
File new labeling exhibits, specification sheets, expiration authorizations, and storage documentation master packaging orders in appropriate files.
Coordinate testing/release of work in process with production, QA and SCM departments.
Prepare and maintain essential databases, such as metal reject reports, QA product labels and release chart; copy and distribute data as needed.
Maintain batch manufacturing record files according to storage procedures.
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.).
Hiring Organization: Rose International
Position Number: 487193
Industry: Biotech/Healthcare
Job Title: QA Documentation Assistant
Job Location: Myerstown, PA, USA, 17067
Work Model: Onsite
Shift: M-F start 7:00am
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 6
Min Hourly Rate($): 30.00
Max Hourly Rate($): 36.00
Must Have Skills/Attributes: Audit, Document Control Procedures, Document Review, GMP, SAP
Experience Desired: Experience in document review/auditing role in a cGMP industry (5 yrs); Experience using SAP, MES, or other automated inventory system (1 yrs)
Required Minimum Education: High School Diploma or equivalent
**C2C is not available**
Job Description
***Drug screen & criminal background check will be required
EDUCATION / EXPERIENCE REQUIREMENTS
High School degree or GED with at least 5 years of experience in document review/auditing role in a cGMP industry is required.
College background and/or secretarial or administrative certifications a plus.
REQUIRED SKILLS
Strong Personal Computer skills required; Microsoft software preferred.
Previous experience using SAP, MES, or other automated inventory system is required.
Must have excellent interpersonal skills, written and oral communication skills, and have demonstrated ability to work effectively in a team environment.
Must have demonstrated leadership skills in audit/review of cGMP documentation & in various special projects.
Must have demonstrated ability to have good interpretive judgment of records, accurate mathematical calculation skills, organizational skills, and legible handwriting is required.
Physically able to lift up to 50 pounds.
POSITION SUMMARY
In QA Doc/Release, performs usage decisions on inspection lots of packaging components, and intermediates as to conformance to current good manufacturing practices (cGMPs), standard operating procedures (SOPs), and plant quality standards. Review in-process records and quality assurance test results for compliance with specifications and assign disposition. Review and assign expiry dating to process inspection sheets used for finished goods packaging.
RESPONSIBILITIES
Audit all manufacturing and packaging documentation to ensure compliance with all GMP regulations and Bayer standards. Release bulk intermediates and package component materials to ensure timely release to meet production requirements.
Coordinate priorities with Documentation Auditors to ensure top priority work is accomplished in timely fashion.
Review production records (i.e. batch manufacturing, packaging records and MES production reports) for accuracy and completeness; perform mathematical audit of calculations; prepare and maintain batch jackets.
Issue/Reconcile manufacturing and packaging documents for execution according to SOPs in timely manner to support production schedules.
Issue/Reconcile QC laboratory documentation for execution according to SOPs.
Support site practices for document control in issuance/reconciliation of working documents.
File new labeling exhibits, specification sheets, expiration authorizations, and storage documentation master packaging orders in appropriate files.
Coordinate testing/release of work in process with production, QA and SCM departments.
Prepare and maintain essential databases, such as metal reject reports, QA product labels and release chart; copy and distribute data as needed.
Maintain batch manufacturing record files according to storage procedures.
- **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.).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.