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GENERAL SUMMARY OF POSITION:

The Quality Control Microbiology Analyst II is responsible for conducting routine environmental monitoring and water testing and reading, reporting, and interpreting results.  The position requires mandatory second and third shift rotations (about once every 6 weeks) to support 24 hour aseptic filling operations. The position requires occasional weekend sampling.

MAJOR RESPONSIBILITIES:

• Performs assays in the QC Microbiology Laboratory as set forth in SOPs, adhering to cGMP.
• Enters and reviews data in LIMS in a timely manner, utilizes LIMS to manage equipment and media needs for the department.
• Conducts final and in process membrane filtration sterility testing and spread plate bioburden testing.
• Collects water, steam and compressed air.
• Conducts Environmental Monitoring of Cleanrooms, including 24 hour fill coverage approximately once every 6 weeks.
• Conducts Endotoxin and Bioburden Testing of water, rinses and product samples.
• Performs Gram staining and Microbial colony counting.
• Performs autoclave processing and documentation.
• Organizes and compiles data and assists in the analysis of data by statistical procedures as requested by supervisor.
• Oversees the maintenance of lab supplies and reagents and the proper disposal of hazardous material.
• Generates, maintains, and trends assay parameter data for designated assays.
• Takes initiative in solving technical problems that arise. Troubleshoots assay problems with supervisor.
• Participates in writing and revising SOPs, change controls, and incident/deviation reports. 
• Assists in the development and optimization of testing methods.
• Assists in the qualification of new controls, standards and reagents.
• Maintains log books related to inventory and equipment.
• Ensures labs are clean and safe (in compliance with cGMP), and properly stocked.
• Makes detailed observations, analyzes data and interprets results.  Prepares technical reports, data summaries or protocols.
• Performs other additional job related duties as required. 

REQUIRED QUALIFICATIONS:

• Bachelors degree in a scientific discipline
• 2 years relevant experience or equivalent
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
• Prior experience in a cGxP regulated environment.
• Capable of moderately complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong problem solving, time management and organizational skills.  Demonstrated ability to multitask and consistently meet deadlines
• Possesses  well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills. Ability to communicate effectively with others and to train others.
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team
• Prior experience with LIMS is preferred
• The position requires ability to cover mandatory second and third shift rotations (about once every 6 weeks) to support 24 hour aseptic filling operations. The position requires occasional weekend sampling