QC Microbiology Lead — Aseptic Manufacturing

Grand River Aseptic Manufacturing; Grand Rapids (MI); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Benefits from day 1

Paid volunteer time

Paid time off (PTO)

10 paid holidays

Zusammenfassung

Grand River Aseptic Manufacturing in Grand Rapids, MI is seeking a QC Microbiology Supervisor to lead environmental control and microbiology testing in an aseptic processing operation. The role requires coordinating cross-functional teams, driving continuous improvement, and ensuring compliance with quality systems.

Responsibilities include managing routine testing, environmental monitoring, training, CAPA/NCR handling, equipment calibration, method development, and audits as needed.

Qualifikationen

• Bachelor's degree in biology or related discipline.
• Minimum of 5 years' experience in a Microbiology laboratory supporting an aseptic manufacturing process.
• Knowledge of quality control principles in pharma/biopharma/biotech environments.
• Proficient in Microsoft Word, Excel, and Outlook.

Aufgaben

• Manage day to day prioritization of routine, in-process, stability and finished product testing.
• Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities.
• Lead training of all new employees and maintain all training documentation via current system.
• Support the EIR system and assist in any related Laboratory Investigations, CAPA's, or NCR's.
• Oversight of all equipment use and equipment calibration logs.
• Establish and maintain good technique with regards to working in an aseptic environment.
• Independently author or revise internal test methods and standard operating procedures.
• Review EM trending data, quarterly, and annual summary reports.
• Review process and testing documentation as needed to ensure complete and accurate records are maintained.
• Assesses process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes.
• Participate in cross-functional meetings and training sessions with manufacturing operations.
• Coordinate with contract testing laboratories and experts as needed.
• Assist in the conduct of vendor audits as a microbiology subject matter expert, as needed.
• Participate in client and regulatory audits as a microbiology subject matter expert, prepares documents for review and speaks to GRAM processes and procedures to answer auditor questions.

Kenntnisse

Quality control principles

Microsoft Word

Microsoft Excel

Microsoft Outlook

Cross-functional collaboration

Ausbildung

Bachelor's degree in Biology or related discipline

Tools

Environmental monitoring systems

Sterility testing (preferred)

Jobbeschreibung

Grand River Aseptic Manufacturing in Grand Rapids, MI is seeking a QC Microbiology Supervisor to lead environmental control and microbiology testing in an aseptic processing operation. The role requires coordinating cross-functional teams, driving continuous improvement, and ensuring compliance with quality systems.

Responsibilities include managing routine testing, environmental monitoring, training, CAPA/NCR handling, equipment calibration, method development, and audits as needed.