Quality Control Analyst
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.
Required Competencies: 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.
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.