QC Microbiology Specialist I
PCI Pharma Services
Summary
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Job description
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Performs non-routine complex testing, identifies requirements and executes actions as part of change control process.
- Assists and guides others in the lab with routine testing
- Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
- Leads qualification and study directed testing activities
- Reviews and evaluates advanced lab testing results
- Acts a qualified trainer and Subject Matter Expert (SME) of multiple tests
- Supports intermediate investigations of OOS assays and events
- Ensures compliance with cGMP and participates in audits and inspections
- Supports laboratory management and mentors others on the team, as needed
- Leads LEAN lab and six sigma principles and applies them to laboratory processes
- Leads audit readiness and participates/supports for the team
- Performs other duties, as assigned
Qualifications
- High school Diploma, GED, or equivalent credential required; AS degree or BS degree in Microbiology or related scientific field preferred.
- 5-7 years' experience in a cGMP environment; equivalent combination of education and experience will be considered.
Requirements
- High school Diploma, GED, or equivalent credential required
- AS degree or BS degree in Microbiology or related scientific field preferred
- 5-7 years' experience in a cGMP environment
- Equivalent combination of education and experience will be considered
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.