Title:  Associate Analyst, Analytical Lab

Job Summary

In this role you will perform routine and non-routine testing to support product release, including but not limited to environmental monitoring, water testing, and other laboratory functions as needed.

Essential Duties and Responsibilities

• Perform routine and non-routine product and packaging release testing including, but not limited to, bacterial endotoxin, bioburden, particulate, silicone etc.
• Perform routine testing to support the plant functions including, but not limited to environmental monitoring, water testing, personnel monitoring, etc.
• Perform incoming testing for materials, including growth promotion testing in culture media and incoming test for biological indicators.
• Perform microbial identification using the WID-MID software®.
• Review data when required.
• Participate in basic laboratory support functions, such as cleaning, preparing materials and glassware for testing.
• Provide support for validations, method transfer and/or project work.
• Assist in preparation of work instructions, SOPs, and qualification documentation.
• Provide support in internal and external audits.
• Participate (or assist) in identification, investigation (OOS’s) and resolution of problems in the lab.
• Apply required cGMP regulations, data integrity and internal procedures.
• Adhere to established laboratory safety procedures.
• Meet individual and departmental goals as required.
• Willing to work as a team member with self-motivation, adaptability, and a positive attitude to ensure continuous improvement relative to laboratory functions. As well as work independently using established methods and procedures.
• Other responsibilities as assigned.

Education

• Bachelor’s degree in Science, Biology, or a related area preferred

Work Experience

• 1+ years of experience in a similar role preferred
• Experience in a cGMP environment preferred
• Experience with lab instrumentation preferred

Preferred Knowledge, Skills and Abilities

• Fluent in English.
• Good verbal and written communication skills.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems #LI-AP1 #LI-ONSITE

Shift

1st shift (7:00 am - 3:30 pm)