Environmental Compliance Supervisor 2nd Shift

Kindeva Drug Delivery•Brentwood, MO

1d•Onsite

About The Position

This Environmental Compliance (EC) Supervisor role will serve the Brentwood, MO location as part of second (2nd) shift operations with hours from 1400 - 2230, Monday through Friday. Occasional weekend or off shift work may be required to meet departmental and production needs. The EC Supervisor position is responsible for leading a team of environmental monitoring technicians that support 24/7 manufacturing operations. This role provides expertise and oversite for environmental monitoring (EM) and utility monitoring programs, EM excursion investigations, contamination control, inspection readiness, and quality systems within a fast-paced CDMO biopharmaceutical manufacturing environment. This role will collaborate with other EC supervisors to ensure timely completion of all daily, weekly, and monthly sampling, along with the associated documentation review. They will assist in investigations, EM oversight, equipment troubleshooting, CAPA actions and change controls, and regulatory inspection readiness. Additionally, this role will collaborate with manufacturing colleagues and leadership to ensure clear communication regarding production needs, monitoring needs, and any ad hoc sampling that needs to be performed.

Requirements

Bachelor’s Degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, Biochemistry, or related scientific discipline preferred.
3-5 years of pharmaceutical, biotechnology, or CDMO experience in Quality Control, Microbiology, Environmental Monitoring, Quality Systems, or related functions.
1-3 years of leadership experience within EM, Microbiology, or pharmaceutical manufacturing preferred.
Experience in complex investigations and CAPAs or Change Controls.
Experience supporting inspections, audits, and associated responses.
Experience supporting sterile parenteral manufacturing.
Experience with computerized environmental monitoring systems and validation programs.
Environmental monitoring programs and processes
Aseptic Manufacturing
Utility and water system monitoring
Quality Systems
cGMP regulations
Data integrity
ALCOA+
Good Documentation Practices (GDP)
OOS/OOT/OOE Investigations
Deviations
CAPA Systems
Change Control
Risk Management
Inspection readiness programs
MODA Environmental Monitoring Systems (or similar)
LIMS
Electronic Quality Systems
Audit Trail Review
Exceptional scientific and technical judgement.
Excellent attention to detail.
Ability to recognize scientifically implausible results and data anomalies.
Strong technical troubleshooting, including common environmental monitoring equipment.
Ability to assess risk and make sound recommendations.
Investigation and root cause analysis skills.
Excellent written and verbal communication skills.
Proven ability to collaborate effectively across functions and organization levels.
Strong analytical, critical thinking, and decision-making skills.

Responsibilities

Serve as an SME for environmental monitoring, contamination control, and environmental monitoring systems.
Support continuous improvement initiatives to strengthen QC quality systems, compliance, and operational efficiency.
Serve as a technical advisor to QC leadership for quality, compliance, and technical decision-making.
Perform and/or oversee review of EM data packets and MODA samples as needed.
Ensure compliance with cGMP requirements, Data integrity requirements, ALCOA+ principles, and Good Documentation Practices (GDP).
Evaluate raw data, electronic records, audit trails, and laboratory documentation as needed.
Support data integrity remediation activities and risk assessments.
Manage daily, weekly, monthly sample plans and ensure proper completion within the MODA system.
Assist with MODA Environmental Monitoring program updates and workflows to improve operation automation, efficiency and compliance.
Review validation documents associated with MODA implementation and lifecycle management.
Review microbiological and environmental monitoring trends for: Facilities, Utilities, Cleanrooms, Water systems, and Manufacturing operations.
Evaluate data for scientific plausibility and compliance risk.
Identify recurring issues and emerging trends that may impact product quality or patient safety.
Assist with developing recommendations based on trend analysis and risk assessments.
Provide support for complex investigations involving: EM excursions, Water system excursions, OOS, OOT, OOE, Deviations, Contamination events, Data integrity concerns, Laboratory investigations.
Assist with root cause analysis using scientific and risk-based methodologies.
Recommend additional testing, monitoring, or investigative actions when necessary.
Ensure investigations are timely, scientifically justified, and compliant with regulatory expectations.
Partner with QA and functional departments to drive closure of quality events.
Assist with Corrective and Preventative Actions (CAPAs).
Monitor recurrence trends and identify opportunities for systemic improvement.
Serve and an SME as needed during customer audits and regulatory inspections as needed.
Support FDA, EMA, MHRA, and other health authority inspections as needed.
Support associated responses to regulatory observations and commitments.