Packaging Operations Specialist — GMP/QA Support

Almac Group; Souderton (Montgomery County); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, Vision & Dental benefits

PTO 20 days per year

12 holidays per year

Long and Short-term disability

401k company contribution

Professional development programs

Job summary

Almac Group is seeking a Production Specialist (Packaging Operations) for our Audubon, PA location to support on-time production and maintain quality systems. You will handle deviation investigations, batch record issuance, CAPA activity, change requests and SOP maintenance to ensure compliant packaging processes.

The role emphasizes collaboration on projects, validation activities, and continuous improvement of packaging lines, with a 40-hour week and potential extended shifts as needed.

Qualifications

• Required Education: HS Diploma/GED
• Preferred Education: Bachelor’s degree in life science or related field
• Required Work Experience: 3 years in Pharmaceutical or similar GMP environment
• Experience compiling technical documentation (SOPs, Batch Records, Validation protocols)
• Working knowledge of pharmaceutical packaging & manufacturing processes, including cGMPs
• Investigations/Technical Writing
• Lean Manufacturing
• Six Sigma Green or Black Belt Certified
• Experience with packaging equipment such as bottle filling, blister card packaging, labeling, kit assembly

Responsibilities

• Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner
• Generate Change Requests & Production Protocols to support the production schedule
• Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPA’s
• Coordinate the review of trend CAPA’s to determine their effectiveness
• Support Production Batch Record Issuance
• OSM, Material Allocation and Label Generation
• Participate in development projects as required
• Support the delivery of qualification and validation in line with SOPs and cGMP
• Support compiling of Standard Operating Procedures and Cleaning Instruction Records
• Ensure compilation of all documentation (Batch Records, Validation Protocols, etc.) is accurate

Skills

GMP experience

Investigations

Documentation

SOPs

Batch Records

Lean Manufacturing

Six Sigma Green/Black Belt

Process Packaging

Validation protocols

Education

HS Diploma/GED

Bachelor’s degree in life science or related field

Job description

Almac Group is seeking a Production Specialist (Packaging Operations) for our Audubon, PA location to support on-time production and maintain quality systems. You will handle deviation investigations, batch record issuance, CAPA activity, change requests and SOP maintenance to ensure compliant packaging processes.

The role emphasizes collaboration on projects, validation activities, and continuous improvement of packaging lines, with a 40-hour week and potential extended shifts as needed.