Microbiology Sterility Assurance Specialist
Partnering with a well established Pharma partner with over 60 years industry experience, I am looking for an experienced Sterility Assurance Specialist.
With the business refocusing on the Manufacturing of Sterile Injectables, they are looking to build out the Sterility Assurance Program.
This role will offer independence and encourage a 'trial and error' approach to establishing procedures. If you are looking to join an ambitious organisation with clear growth plans both for you and the business, then this could be for you.
Are you passionate about ensuring product quality and compliance with regulatory standards? We’re seeking a skilled Microbiology Sterility Assurance Specialist to join our team.
In this pivotal role, you’ll play an integral part in maintaining sterility assurance, supporting testing processes, and implementing contamination control strategies.
Let’s dive into the details :
Purpose and Scope :
- Evaluate proposed manufacturing processes and associated controls to assess the potential introduction of microbial, endotoxin, and particulate contaminants.
- Provide expertise across all sterility assurance programs, including disinfectant evaluations, resident microflora assessments, airflow pattern testing, and environmental monitoring.
- Participate in internal and external audits, ensuring compliance with regulatory requirements.
- Apply quality improvement tools and techniques, addressing nonconformities, deviations, and barriers to improvement.
- Contribute to projects aimed at enhancing quality performance.
- Create, review, and approve technical documents related to sterility assurance.
- Risk Assessments : Lead or support risk assessments within the sterility assurance domain.
- Root Cause Investigations : Investigate and resolve issues related to sterility assurance.
- Floor-Level Compliance : Ensure adherence to environmental monitoring, aseptic process simulations, and other sterility assurance protocols on the manufacturing floor.
- Procedure Maintenance : Author and maintain quality system procedures, policies, and forms.
- Industry Alignment : Evaluate procedures for compliance with industry standards.
If you’re ready to make a difference in sterility assurance, join us! Let’s create a safer, cleaner world together.
Microbiology Sterility Assurance Specialist
Microbiology Sterility Assurance Specialist. Are you passionate about ensuring product quality and compliance with regulatory standards? We’re seeking a skilled Microbiology Sterility Assurance Specialist to join our team. Partnering with a well established Pharma partner with over 60 years industry...
Travel Physical Therapy Assistant - $1,042 per week
LRS Healthcare - Lab is seeking a travel Physical Therapy Assistant for a travel job in Longmont, Colorado. LRS Healthcare - Lab Job ID #08212024-N. We have many positions available across the country, so let's discuss what would be a good fit for you!. ...
Senior Project Manager-Medical Device
Manage projects of varying size and complexity and tailor project management tools according to the scope of the project. Partner with project team to develop project schedule, budget, and resource needs for assigned projects. Create project risk management plans and develop risk response plan for k...
Senior Quality Assurance Specialist
A company is looking for a Senior Quality Assurance Specialist to support quality assurance initiatives in the clinical research field. ...
Principal Analytical Chemist
Applies analytical and organic chemistry skills to the improvement of processes. Initiates and executes the development of new and innovative analytical chemistry and methodology. Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or e...
Assistant Operations Chemist
An Assistant Operations Chemist performs the following duties and responsibilities with oversight of a higher level Operations Chemist and/or Supervisor. ...
Medical Assistant
Any Lab Test Now is a leading provider of direct-access lab testing services, allowing individuals to take control of their health by conveniently and affordably accessing a wide variety of lab tests without the need for a doctor's order. We have a supportive culture across our team, and we are ...
Laboratory Analytical Chemist
In addition, simple wet chemistry tests will also be required. Prior experience in a chemistry lab setting is a plus for this position. Performingsome wet chemistry tests. Chemistry or Chemical Engineering. ...
Dental Lab Technician
Looking for artists! Currently we are hiring hardworking, dedicated, and experienced Dental Lab Technicians. Experienced technicians and entry-level technicians are encouraged to apply. We are a fast growing, high-end boutique lab that is known for exceptional quality and are looking for a highly mo...
Travel Medical Lab Technician in Longmont, CO
With access to thousands of Hospitals and community facilities across the country, our mission is to deliver travel staffing solutions in line with our core values of Transparency, Positivity, Integrity, Service, Respect, and Collaboration. ...