Clinical Packaging Lead — 2nd Shift, Batch Records

Catalent Pharma Solutions; Philadelphia (Philadelphia County); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive PTO and holidays

Benefits from day one

Tuition reimbursement

Job summary

Catalent’s Philadelphia, Pennsylvania site is seeking a Clinical Production Specialist to oversee packaging of clinical trial supplies and supervise staff within a specific batch-record operation. The role emphasizes safety, quality, and adherence to timelines in a 2nd shift setting.

You will manage multiple packaging operations, including automated bottle lines, form-fill-seal, labeling, and kit assembly, while ensuring accurate data entry and batch record review.

Qualifications

• Minimum Requirements: High School Diploma or GED; Associate Degree preferred.
• 1+ years of clinical, contract, or production experience.
• Computer proficiency including Microsoft Word.
• Knowledge of current Good Manufacturing Practices (cGMP), DEA, and OSHA regulations.
• Knowledge of packaging equipment in a Just-in-Time environment.

Responsibilities

• Monitor, organize, and perform all functions related to packaging of clinical trial supplies, ensuring compliance with GMP, SOPs and regulatory requirements (FDA, DEA, OSHA).
• Oversee batch record operations in primary and secondary production rooms with automated packaging equipment.
• Manage production involving manual and automated labeling on bottles, cards, cartons, kits, vials, syringes and ampoules; maintain materials and supplies.
• Ensure correct placement of look-alike products in blister units, cards and bottles; handle refrigerated and frozen clinical material.
• Enter data in batch records and logbooks; review manufacturing and packaging batch records timely.
• Ensure security, accountability, and reconciliation of controlled substances.
• Manage staging, reconciliation, and inventory label generation in the ERP (JD Edwards).
• All other duties as assigned.

Skills

cGMP knowledge

DEA regulations

OSHA regulations

Packaging equipment knowledge

Education

High School Diploma or GED

Associate Degree

Tools

JD Edwards

Microsoft Word

Job description

Catalent’s Philadelphia, Pennsylvania site is seeking a Clinical Production Specialist to oversee packaging of clinical trial supplies and supervise staff within a specific batch-record operation. The role emphasizes safety, quality, and adherence to timelines in a 2nd shift setting.

You will manage multiple packaging operations, including automated bottle lines, form-fill-seal, labeling, and kit assembly, while ensuring accurate data entry and batch record review.