QC Microbiology Analyst III

Expiring today

Employer
Vivid Technologies
Location
Allendale, New Jersey, US
Salary
Competitive
Posted
Jun 05, 2021
Closes
Jun 13, 2021
Ref
2230276015
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Job Description
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

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