- Serves as the subject matter expertise to the EM and sampling activities. Under the direction of the Environmental Monitoring and Sampling Manager, supervise the environmental monitoring program and technicians; serves as a facilitator to the team members.
- Participate in the recruitment and selection of staff; provide or coordinate staff training; work with employees to ensure performance is in accordance to expectations; work with manager and human resources department for guidance in managing any performance deviation.
- Plan, prioritize, assign, supervise and review the work of staff involved in the collection. Establish schedules for the collection of all EM sampling; implement policies and procedures. Ensure all necessary testing is carried out and in accordance with internal procedures, protocols, and cGMP's.
- Conduct performance evaluations for the assigned EM and Sampling Technicians.
- Ensure strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning/preparation practices and procedures, and compliance with quality standards and regulations.
- Provide support to Quality Team in internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner.
- Participates in the drafting and review of technical documents and procedures to ensure compliance in the event that changes are required.
- Support continuous operations by periodically evaluating workload versus resources to ensure coverage with changing priorities.
- Support the Environmental Monitoring and Sampling Manager in the development of proposals, as well as in the preparation of consumables and overall budget planning.
- Identify and mitigate risks to ensure compliance and escalate any issues with Environmental Monitoring and Sampling Manager.
- Monitor and improve key performance indicators (KPIs) related to lab efficiency, safety, quality, delivery, inventory and productivity.
- Drive continuous improvement initiatives and lead cross-functional projects as a subject matter expert (SME).
Oversee the Environmental Monitoring and Sampling team and activities when Environmental Monitoring Manager is not available (vacation, sick, etc.)
Educational
Bachelor’s Degree is required; Sciences; Biology, Biotechnology, Microbiology, Industrial Microbiology or Engineering disciplines is highly preferred OR Associate’s degree plus 6
[TS1] years of directly experience in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology) OR High School degree plus 8 years of directly in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology)
- At least five (5) years of directly experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry
- Previous experience with three (3) to five (5) years of in a supervisory / managerial position, with at least three (3) years of experience in Parenteral or Pharmaceutical Industry
- Two (2) years of experience in GMP Environmental Monitoring or Utilities Sampling activities is preferred. Experience in clean room environmental monitoring and aseptic technique is a preferred.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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