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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

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We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Environmental Monitoring Specialist

Job Description

  • Location: Phoenix, AZ
  • Type: Contract
  • Job #72877

Our client, a leading pharmaceutical company, is hiring an Environmental Monitoring Specialist on a contract basis.

Work Location

Phoenix, AZ

Summary

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 organizations 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.

• Bachelors Degree, particularly in Microbiology or Science related field, preferred but not required.

• An equivalent combination of education / experience may substitute.

 

 

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