API/QCI Supervisor

Stallergenes Greer U.S.; Lenoir (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Stallergenes Greer U.S. is seeking a Laboratory Supervisor to oversee API Microbiology and QCI operations. You will release materials and results promptly, supervise a team across 3 intertwined categories, and lead investigations under QA systems.

Strong knowledge of microbiology, documentation controls, and RMA processes is required. Minimum five years in a lab setting with 2–3 years in supervision or overseeing at least six staff, plus familiarity with JDE and MasterControl, is expected.

Qualifications

• Minimum five years in a laboratory environment.
• Experience with bioburden testing, organism identification, environmental monitoring, and aseptic technique.
• 2–3 years of document review for data release or materials.
• 2–3 years of supervisor experience or direct oversight of at least 6 people.

Responsibilities

• Release of raw materials, components, and finished products from QCI in a timely manner.
• Release of in-process and finished product results from API in a timely manner.
• Own equipment in API Microbiology and QCI; perform or delegate OOT investigations.
• Review and approve API Microbiology OOS investigations.
• Own DMR system and support Change notification process.
• RMA review and approval; oversee item/material specifications at site.
• Supervise 6 personnel across API Microbiology, QCI, QC Material Specialist.
• Coordinate day-to-day operations, work planning, and workload prioritization.
• Ensure coverage during time off; participate in cross-department projects.
• Supervise API Microbiology Lab and QCI personnel; conduct performance evaluations and trainings.
• Track KPIs and drive quality metrics.

Skills

Laboratory supervision

Microbiology techniques

Documentation practices

Education

BSc in Science/Microbiology

Tools

JDE database

MasterControl

Job description

• Responsible for the release of raw materials, components, and finished products from QCI in a timely manner.
• Responsible for the release of in process and finished product results from API in a timely manner
• Owner of equipment within QCI and API Microbiology, perform OOT investigations as needed
• Perform or delegate OOT investigations for equipment
• Review and Approve API Microbiology OOS investigations
• Owner of DMR system and support for Change notification process
• RMA review and approval
• Oversight of all specification for receiving items/materials at site
• Supervise a group of 6 individuals that are in 3 different categories that are intertwined: API Microbiology, QCI, QC Material specialist.
• Organize and coordinate day to day operation such as work planning and workload prioritization.
• Coordinate time off to ensure coverage for workload.
• Work in cross departmental teams to assist with projects and high priorities for the business (on average week con
• This individual will also supervise API Microbiology Laboratory and QCI personnel, conduct performance evaluation and ensure personnel training.
• Responsible for keeping track of Key Performance indicators

Requirements:

• Minimum of five years of experience in a laboratory environment
• Must demonstrate understanding in microbiology laboratory techniques such as bioburden testing, identification of fungal and bacterial organisms, identification of pollens, identification of mites/insects, purity checks for products, environmental monitoring, and aseptic technique.
• 2-3 years of document review for release of data, materials or products
• 2-3 years of Supervisor experience or direct oversight of a minimum of 6 individuals
• Familiar with Good documentation practices
• Familiar with Quality System forms-Deviation Investigations, Event Investigations, Management of Changes, Building Management System Out of Specifications, Out of Tolerance Investigations, Microbiology Out of Specifications
• Should have experience with Documentation Revision in a quality system
• Knowledge of JDE database
• MasterControl
• Any experience with Return Material Authorization (RMA)
• Discrepant Material Investigations

Education Requirements

This position requires the following minimum education:

• Baccalaureate degree in Science/ Preferably in Microbiology