API/QCI Supervisor

Stallergenes Greer; United States; On-site; USD 75,000 - 110,000; Full time

Job summary

Stallergenes Greer International AG is seeking a Laboratory Operations Supervisor to lead API Microbiology, QCI, and QC Material teams. You will oversee release of materials and results, manage OOT investigations, and ensure training and KPI tracking.

The role requires a strong microbiology background and quality system experience. The position emphasizes cross-functional collaboration, timely releases, and adherence to GMP practices across multiple sites, with a focus on supervision of 6 staff

Qualifications

• Minimum five years in a laboratory environment.
• Experience in microbiology techniques and environmental monitoring.
• 2–3 years of document review for release of data/products.
• 2–3 years of supervisor experience (6+ reports).
• Familiar with quality system forms and investigations.

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.
• Supervise API Microbiology, QCI, QC Material Specialist teams (6 people).
• Organize day-to-day operations, workload prioritization, and time off.
• Oversee OOT investigations and performance evaluations; ensure training.
• Maintain KPI tracking and participate in cross-department projects.

Skills

Microbiology

OOS investigations

QMS

Documentation practices

Leadership

RMA

JDE database

MasterControl

Education

Bachelor's degree in Science (Microbiology preferred)

Tools

JDE database

MasterControl

RMA processes

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

About STALLERGENES GREER International AG

Stallergenes Greeris an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory,food and venom allergies through the development and marketing of Allergenic Immunotherapy treatments.

Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.

Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.

With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44countries.

Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment?

This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:

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