SDO_Operator
PCI Pharma Services
Summary
The Operator I is responsible for producing finished packaged and/or labeled clinical product (including kits) for PCI's clients as per the batch instructions and following the principles of current Good Manufacturing Practice (cGMP).
Job description
Summary of Objective
The Operator I is responsible for producing finished packaged and/or labeled clinical product (including kits) for PCI's clients as per the batch instructions and following the principles of current Good Manufacturing Practice (cGMP).
Essential Duties and Responsibilities
- Produce finished packaged and/or labeled product to established specifications while adhering to cGMP and Standard Operating Procedures.
- Follow good documentation practices on all documentation.
- Operate packaging and/or labeling equipment safely and efficiently.
- Package according to clinical packaging requirements including control of labeling and active/placebo supplies for various clinical studies including blinded studies.
- May require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
- Attendance to work is an essential function of this position.
- Perform other duties as assigned by Manager/Supervisor.
Qualifications
Required: High School Diploma or GED and/or 1-3 months related experience and/or training. Basic mathematical skills, basic reasoning, and ability to follow written or oral instructions.
Preferred: Ability to work effectively with other operators; previous pharmaceutical clinical packaging and/or labeling experience; capable of maintaining established schedule; good manual dexterity; knowledge and understanding of cGMP; basic communication and mathematical skills; ability to multi-task effectively.
Requirements
- High School Diploma or GED
- 1-3 months related experience and/or training
- Basic mathematical skills
- Basic reasoning ability
- Knowledge and understanding of cGMP
- Good manual dexterity
- Ability to multi-task effectively
- Basic communication skills
Benefits
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- 401(k) Plan
- Annual Performance Bonus
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.