Packaging Associate II - 3rd Shift

System One, Inc.; Macungie (Lehigh County); On-site; USD 26,000 - 29,000; Full time

Job summary

System One, Inc. is seeking a Packaging Associate II for the 3rd shift in Macungie, PA. This contract-to-hire role requires GMP-compliant packaging, attention to detail, and accurate documentation as you work on batch records and quality checks.

You will perform inspections, support production goals, and ensure proper packaging documentation, while adhering to AQL and regulatory requirements. Compensation starts at $19.00 per hour with a $2 shift differential, Sunday-Thursday 11:00 PM–7:00 AM.

Qualifications

• High School diploma or equivalent.
• Experience with GMP in a regulated environment and documentation verification.
• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations.
• Ability to pass a GMP assessment during orientation at the Allentown site.

Responsibilities

• Ensure adherence to and enforce GMP compliance during packaging operations.
• Perform visual, functional, destructive, and count quality inspections of units during packaging, verifying component attributes and documenting results.
• Review and verify documentation, including batch records and component attributes, supporting compliance with regulatory requirements and customer specifications.
• Read and understand process steps within packaging records to ensure process adherence and quality during the packaging process.
• Assist with overall production efficiency in the assigned area, supporting team efforts to meet production goals.
• Inspect units for quality as they are packaged, supporting quality assurance and regulatory compliance.
• Verify the accuracy and completeness of packaging documentation, ensuring all information aligns with AQL requirements and proper support documentation is maintained.

Skills

GMP knowledge

Documentation verification

Regulatory compliance

Education

High School diploma

Job description

Job Title: Packaging Associate II - 3rd Shift

Location: Macungie, PA 18062

Type: Contract To Hire

Compensation: $19.00/hour + $2 shift differential

Hours: 11:00PM-7:00AM, Sunday-Thursday

Overview

Established and growing pharmaceutical manufacturing company is seeking to add quality minded packaging associates to their growing team.

Responsibilities

• Ensure adherence to and enforce GMP compliance during packaging operations.
• Perform visual, functional, destructive, and count quality inspections of units during packaging, verifying component attributes and documenting results.
• Review and verify documentation, including batch records and component attributes, supporting compliance with regulatory requirements and customer specifications.
• Read and understand process steps within packaging records to ensure process adherence and quality during the packaging process.
• Assist with overall production efficiency in the assigned area, supporting team efforts to meet production goals.
• Inspect units for quality as they are packaged, supporting quality assurance and regulatory compliance.
• Verify the accuracy and completeness of packaging documentation, ensuring all information aligns with AQL requirements and proper support documentation is maintained.

Requirements

• High School diploma or equivalent
• Experience with/knowledge of GMP quality or manufacturing in a regulated environment, including visual inspections and documentation verification
• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations for controlled substances
• Ability to pass a GMP assessment during orientation at the Allentown site

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.