Quality Control Microbiologist
18 hours ago
Lynkx Staffing LLC is seeking a highly skilled Quality Control Microbiologist to join our team. As a Quality Control Microbiologist, you will play a critical role in ensuring the quality and safety of our products.
Key Responsibilities- Perform environmental monitoring activities, including non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.
- Coordinate data for batch release and participate in project/client meetings, providing scientific and technical expertise.
- Author and revise environmental monitoring procedures, as well as Standard Operating Procedures, Work Instructions, Forms, and Protocols.
- Review investigations and document non-confirming events and environmental excursions.
- Apply expertise of compliance requirements to maintain an inspection-ready state.
- Participate and act as subject matter expert during audits/inspections.
- Develop and train QC Microbiology Analysts on relevant business processes.
- Process purchase orders for outsourced testing and lab supplies.
- Coordinate work orders.
- Bachelor's degree in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
- GxP/GDP Trained.
- Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred).
- Proficient knowledge of ISO and EU standards.
- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
- Strong written and oral communication skills.
- Strong technical writing skills.
- Technical training experience.
- Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
- Must have the ability to work in a team-oriented environment and with clients.
- Must be able to work during the weekend, holidays, and as required by the company.
- Must be able to handle the standard/moderate noise of the manufacturing facility.
- While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
- Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.
- Must have the ability to work in a team-oriented environment and with clients.
- Must be able to work during the weekend, holidays, and as required by the company.
- Must be able to handle the standard/moderate noise of the manufacturing facility.
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