Lead Microbiologist SME to lead and provide support to Projects involving Process Validations, Sterilization Assurance for New and Existing Product families working within the QA laboratory testing group. Activities may involve protocol writing, review and approval. Participate in all laboratory related activities including but not limited to coordination, execution and reporting of correspondent microbiology laboratory process requirements. This role may be required to oversee or train lab technicians, internal and external customers utilizing the lab appropriately, and assuring that all documented lab safety practices are followed.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Coordinates support of Microbiology deliverables while keeping focused on all safety compliance of the lab and GLP, GMP requirements related to any documented results or reports. Contributes to the overall, calibration, inventorying and sample tracking within the lab.
Maintains readiness for any audit by internal or external sources.
As necessary, implements or participates in root-cause analysis and corrective action for any CAPAs within the lab areas.
Efficiently responds to common sample requests for analyses from, Laboratory Staff, Plant Staff or internal personnel.
Training and evaluation of all inspection/audit functions.
Support and coordinate (as required) regulatory and internal audit activities.
Perform microbiology laboratory audits & ensure compliances to procedures.
Drive quality awareness in all direct personnel including the production supervisors and support functions for the microbiological processes.
Communicate clearly & effectively to the quality organizations and sterilization sciences on all issues that require additional support, escalation or resources to effectively manage or resolve.
T imely, accurate communication of quality data and audit results to the appropriate personnel.
To support & educate microbiology laboratory personnel in the interpretation of specifications & quality policies governing the laboratory areas.
Promoting a "quality first" mentality to the employee base.
May perform other duties and responsibilities as assigned.
Promotion of the microbiology laboratory for growth with current and potential customers.
EDUCATION & EXPERIENCE REQUIREMENTS
Bachelor’s in Microbiology or related Life Sciences.
Masters or PHD a plus in Microbiology or related Life Sciences
6 years minimum working experience in microbiological and/or sterilization related field.
Knowledge of Sterilization Standards and requirements for Medical Devices.
Knowledge of Stability of Medical Devices is a plus.
Knowledge of GMP laboratory including but not limited to microbiological laboratory environment.
Good inter-personal and skills.
Goal oriented and action-focused, pragmatic and self-disciplined
Good at multiple task planning, organizing, and communication
Organizes verbal and written ideas clearly and uses an appropriate business and scientific
Ability to effectively present information to management and/or customer personnel; Use of presentation or database software.
Accountable as a team player, building relationships both internal and external, to support the Team approach.
LABORATORY TASK RESPONSIBILITIES
· Ensures all of the requested task’s requirements and/or objectives are understood and properly implemented, to achieve the necessary results for the samples being analyzed within the lab area.
· Responsible for safe work habits and mitigation of those risks to a safe work environment, or elevating those risks to management.
· Facilitates communication, as appropriate, to other Laboratory Staff and Laboratory Management.
· Understands and exceeds internal and external needs and expectations on all customers of the lab.
· Assures compliance to all safety and health rules and regulations associated with this position and as directed by management.
· Comply and follow all procedures within the company security policy, GMP and good lab practices (GLP).
· May perform other duties and responsibilities as assigned.
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