Associate Analyst, QC Microbiology
Phoenix Metro Area, AZ
The Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The Associate Analyst 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.
Knowledge, Skills, and Abilities
Basic proficiency in MS Word, Outlook, and Excel programs.
Basic experience with various microbiological testing and environmental monitoring techniques.
Basic knowledge of electronic laboratory management systems.
Strong attention to detail.
Basic organizational skills.
Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring.
Basic written and verbal communication skills.
Ability to gown and maintain a sterile work environment.
Ability to accurately and completely understand and follow SOP, test method and cGMP requirements; uses good judgement and follows procedures.
Basic GMP documentation skills.
Knowledge of laboratory safety practices.
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.
Willingness to learn and share knowledge.
Communicates effectively with peers, management and cross-functionally across the site.
Basic knowledge of laboratory and aseptic processes.
Ability to work under regular supervision.
Basic critical reasoning and decision-making skills.
Ability to pass an initial full physical with annual monitoring.
Ability to deal appropriately with regulatory agencies during regulatory and non-regulatory inspections.
Duties and Responsibilities
Performs routine laboratory and EM activities.
Prepares schedules and sample labels.
Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagent QC, BI testing.
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.
Performs environmental monitoring activities in support of manufacturing.
Collects utility samples for analysis.
Maintain qualification status on aseptic gowning, etc.
Demonstrates aseptic technique when performing a Microbiological Test or EM.
Perform testing/monitoring activities associated with protocols or special projects as required.
Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility.
Communicates appropriately with peers and Laboratory Management regarding scheduled duties.
Uses tracking tools as appropriate (EM batch release, sample trackers, etc.)
Communicate effectively with management regarding more complex issues.
Participate in departmental training initiatives.
Document training per procedural and cGMP requirements.
Actively seeks out opportunities to learn from others within and outside the department.
Assist other analysts, freely sharing knowledge and experience.
Executes best practices in the laboratory
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.
Education and Experience
High school diploma or equivalent required.
Bachelor s Degree, particularly in Microbiology or Science related field, preferred.
An equivalent combination of education / experience may substitute.
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.
This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
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.