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Job Description: Four (4) positions available - Two (2) on 1st Shift (0600-1430, Mon-Fri) and Two (2) on 2nd Shift (1400-2230, Mon-Fri).
Position: Environmental Monitoring Specialist, QC Microbiology [Contingent]
Manager: Supervisor, QC Microbiology
Location: Phoenix, Arizona
1. Purpose and Scope of Position
The Environmental Monitoring (EM) Specialist, QC Microbiology, is contingent role responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The EM Specialist is also responsible for peer review and support activities in the laboratory to ensure smooth laboratory operation in accordance with the organization’s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.
2. Required Competencies: Knowledge, Skills, and Abilities
• Ability to accurately and completely understand and follow SOP, test method and cGMP requirements; uses good judgement and follows procedures.
• Ability to complete/maintain gown qualifications into cleanrooms and maintain appropriate cleanroom behavior.
• Ability to deal appropriately with regulatory agencies during regulatory and non-regulatory inspections.
• Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks; cooperative and works well with a team.
• Ability to work under regular supervision.
• Basic critical reasoning and decision-making skills.
• Basic experience with various microbiological testing and environmental monitoring techniques.
• Basic GMP documentation skills.
• Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring.
• Basic knowledge of electronic laboratory management systems.
• Basic knowledge of laboratory and aseptic processes.
• Basic organizational skills.
• Basic proficiency in MS Word, Outlook, and Excel programs.
• Basic written and verbal communication skills.
• Communicates effectively with peers, management and cross-functionally across the site.
• Knowledge of laboratory safety practices.
• Strong attention to detail.
• Willingness to learn and share knowledge.
3. Duties and Responsibilities
Performs routine laboratory and EM activities.
• Prepares schedules and sample labels from Laboratory Management System(s).
• Performs environmental monitoring activities in support of manufacturing, including cleanroom, water, and compressed gas sampling.
• Aseptically prepares materials for entry into the manufacturing suite cleanrooms.
• Operates laboratory equipment used to provide sterile and depyrogenated materials.
• Read EM and testing plates and assess against alert and action levels as appropriate.
• Performs microbial isolation techniques, Gram stains and supports microbial identification process.
• Performance routine maintenance and housekeeping activities for laboratories and equipment/instrumentation per procedure.
• Performs inventory activities, including but not limited to completing inventory at predetermined frequency and on adhoc basis, stocking, unboxing materials, disposal of expired materials, etc.
• Demonstrates aseptic technique when performing a Microbiological Test or EM.
• Communicates appropriately with peers and Laboratory Management regarding scheduled duties.
• Uses tracking tools as appropriate (EM batch release, sample trackers, etc.)
• Administrative tasks.
• Paperwork management and tracking.
• Communicate effectively with management regarding more complex issues.
Participate in departmental training initiatives.
• Document training per procedural and cGMP requirements.
• Assist other analysts, freely sharing knowledge and experience.
• Executes best practices in the laboratory.
Perform peer review of testing data.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Ensure all testing is performed in a compliant matter.
• Complete all review in accordance with required timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Performs general laboratory duties as assigned.
4. Education and Experience
• High school diploma or equivalent required.
• Bachelor’s Degree, particularly in Microbiology or Science related field, preferred but not required.
• An equivalent combination of education / experience may substitute.
5. Working Conditions
• The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown requirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
• The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required.
• The incumbent may analyze data and work with spreadsheets and graphs on a daily basis.
• The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day.
• The incumbent must be able to lift/carry not more than 25 pounds.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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