Packaging Associate II - 1st Shift

System One; Macungie (Lehigh County); On-site; USD 22,000 - 30,000; Full time

Job summary

System One is seeking a Packaging Associate II for 1st shift in Macungie, PA. This contract-to-hire role pays $19.00 per hour and runs 7:00 AM to 3:00 PM, Monday through Friday, within a pharmaceutical manufacturing setting.

Responsibilities include GMP compliance, quality inspections, and documentation verification, ensuring finished goods meet batch records. Candidates should have a high school diploma and prior GMP experience.

Qualifications

• High School diploma or equivalent.
• Experience with GMP quality or manufacturing in a regulated environment, including visual inspections and document verification.
• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations for controlled substances.
• Ability to perform quality inspections and support GMP compliance.
• Strong attention to detail and documentation skills.

Responsibilities

• Adhere to and enforce GMP compliance, perform quality inspections related to contract packaging, including equipment challenges and verification, components, bulk product, work-in-process, and finished goods
• Read and understand process steps within the packaging record to ensure compliance during the packaging process
• Assist with overall efficiency of the production within the assigned rooms
• Inspect units for quality as they are packaged, performing visual, functional, destructive, and count checks as required per packaging record and AQL requirements
• Verify the accuracy, completeness, and supported documentation of the packaging requirements outlined in the Batch Record and ensure all are supported by appropriate documentation

Skills

Attention to detail

Documentation skills

GMP compliance understanding

Education

High School diploma or equivalent

Job description

Job Title: Packaging Associate II - 1st Shift

Location: Macungie, PA

Type: Contract To Hire

Compensation: $19.00

Hours: 7:00AM-3:00PM, M-F

Overview

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

Responsibilities

• Adhere to and enforce GMP compliance, perform quality inspections related to contract packaging, including equipment challenges and verification, components, bulk product, work-in-process, and finished goods
• Read and understand process steps within the packaging record to ensure compliance during the packaging process
• Assist with overall efficiency of the production within the assigned rooms
• Inspect units for quality as they are packaged, performing visual, functional, destructive, and count checks as required per packaging record and AQL requirements
• Verify the accuracy, completeness, and supported documentation of the packaging requirements outlined in the Batch Record and ensure all are supported by appropriate documentation

Requirements

• High School diploma or equivalent.
• Experience with GMP quality or manufacturing in a regulated environment, including visual inspections and document verification.
• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations for controlled substances.
• Ability to perform quality inspections and support GMP compliance.
• Strong attention to detail and documentation skills.

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.