QC Microbiology Analyst III

RHO Consulting Services
Allendale, New Jersey, US
Jul 12, 2021
Aug 06, 2021
Employment Type
Full time
Salary Type
This position will report into the Supervisor of QC Microbiology. The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. Essential Functions and Responsibilities: Under the direction of the Supervisor of QC Microbiology, responsibilities of the QC Microbiology Analyst III will include but are not limited to: Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Coordinates data for batch release Participation in project/client meetings and communications, providing scientific and technical expertise Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols Review of investigations and documentation of 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 Analyst II on relevant business processes Processing of purchase orders for outsourced testing and lab supplies Coordinates work orders Other duties as assigned Qualifications: BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry Competencies: 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 Supervisory Responsibility: This job has no supervisory responsibilities. Minimum Required Training: (contingent on the ability to obtain a qualified gowning status within 90 days of start date.) GxP/GDP Training Safety Training Working Environment: 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 Physical Requirements: The QC Microbiology Analyst III must be able to maintain aseptic behavior within a cleanroom environment for an extended period. Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear Direct reports: N/A