Microbiology & Environmental Compliance Specialist - Onsite

Kindeva-Drug-Delivery-Careers

Brentwood (MO)

On-site

USD 90,000 - 150,000

Full time

13 days ago
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Benefits offered by this job

Competitive compensation
Performance bonus
Career development
Mentorship

Job summary

Kindeva-Drug-Delivery-Careers is seeking an Environmental Compliance (EC) and Microbiology Technical Specialist in St. Louis, MO, bridging Brentwood and Bridgeton facilities. 0800-1630, Mon-Fri, with occasional additional hours.

You will provide site-wide microbiology compliance expertise, EM oversight, and support for CAPA, investigations, and regulatory readiness. The role covers MODA systems, water monitoring, EMPQ, data integrity, and contamination control within a fast-paced CDMO

Qualifications

  • Bachelor’s Degree in Microbiology, Biology, Biotechnology, Biochemistry, or related discipline.
  • 3–5 years in pharma/CDMO in QC, Microbiology, EM, Quality Systems, or related functions.
  • Experience in complex investigations and CAPAs or Change Controls.
  • Experience supporting inspections, audits, and regulatory responses.
  • Experience supporting sterile parenteral manufacturing.
  • Experience with computerized EM systems and validation programs.

Responsibilities

  • Serve as site SME for microbiological compliance, EM, contamination control, and QC quality systems.
  • Assist in investigations, CAPA development, EM oversight, trend review and analysis, and regulatory inspection readiness.
  • Ensure EM programs and water monitoring remain in control, scientifically sound, and compliant with global regulations.
  • Act as SME for EM, contamination control, water monitoring, media fill programs, and EMPQ activities.
  • Provide technical support for EM investigations, CAPA actions, and regulatory responses.

Skills

Microbiology expertise
Environmental monitoring
Investigation leadership
CAPA management
Data integrity
Regulatory inspections
Quality management systems
Root cause analysis
Cross-functional collaboration

Education

Bachelor’s degree in Microbiology or related

Tools

LIMS
Electronic Quality Systems
MODA Environmental Monitoring
CSV (Computerized System Validation)

Job description

Kindeva-Drug-Delivery-Careers is seeking an Environmental Compliance (EC) and Microbiology Technical Specialist in St. Louis, MO, bridging Brentwood and Bridgeton facilities. 0800-1630, Mon-Fri, with occasional additional hours.

You will provide site-wide microbiology compliance expertise, EM oversight, and support for CAPA, investigations, and regulatory readiness. The role covers MODA systems, water monitoring, EMPQ, data integrity, and contamination control within a fast-paced CDMO

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