Lead QC Microbiology & GMP Investigations

Avid Bioservices; Tustin (CA); On-site; USD 67,200 - 84,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking an experienced microbiology professional to oversee microbiological testing in GMP manufacturing settings. You will write and approve protocols and reports for microbiological studies and lead investigations to identify root causes and CAPAs.

You will monitor environmental samples, train staff, and ensure compliance with cGMP, USP, EP, and Annex 1. This full-time onsite role offers competitive compensation and comprehensive benefits while contributing to

Qualifications

• B.S. in Microbiology or related field with at least 5 years in a GMP microbiology lab.
• Experience with protocol and report writing; root cause investigations and CAPA actions; growth promotion testing; bioburden testing; gram staining; aseptic technique; contamination prevention.
• Knowledge of cGMP and working in controlled environments
• Working knowledge of USP, EP, and Annex 1

Responsibilities

• Perform DRs/OOLs/OOSs investigations and determine root cause and CAPAs.
• Lead continuous improvement projects including SOP/test method reviews and updating procedures to ensure compliance.
• Lead various microbiological studies and write/approve protocol and reports for the study.
• Perform data review of environmental monitoring and prepare environmental monitoring data trending reports.
• Oversee microbiological tests such as bioburden, growth promotion, and gram stain for samples submitted to the QCM lab.
• Train employees on microbiological test methods and Global SOPs.
• Direct activities of functional areas through direct reports; represent QCM in interdepartmental meetings.
• Perform other duties as assigned.

Skills

Root cause investigations

CAPA implementation

Environmental monitoring

GMP knowledge

Aseptic technique

Data review

Training others

Education

B.S. in Microbiology or related field

Job description

Avid Bioservices in California is seeking an experienced microbiology professional to oversee microbiological testing in GMP manufacturing settings. You will write and approve protocols and reports for microbiological studies and lead investigations to identify root causes and CAPAs.

You will monitor environmental samples, train staff, and ensure compliance with cGMP, USP, EP, and Annex 1. This full-time onsite role offers competitive compensation and comprehensive benefits while contributing to