Laboratory Analyst - Entry Level

Responsible for: bulk buffer formulation, bead dropping using a beadulator, loading and unloading beads from the lyophilizer, sieving of beads, aliquoting and labeling. Apply basic analytical skills or scientific methods or operational processes to perform straightforward activities with close supervision.

Shift Hours: Sunday through Wednesday;3: 00 PM to 1: 30 AM (4x10 hour shifts)

Description:
Entry level position responsible for supporting the Bulk Buffer, Reagents and Bead production laboratories by following good documentation practices (cGDP) and relevant standard operating procedures (SOPs). Complete assigned tasks and ensure all activities are compliant with the company’s quality, safety and departmental policies and standards. Apply basic analytical skills or scientific methods or operational processes to perform straightforward activities with close supervision.

ESSENTIAL JOB RESPONSIBILITIES:
•Work safely with hazardous chemicals and follow all safety policies fostering a safe work environment
•Immediately report all safety concerns including injuries and safety suggestions
•Use standard operating procedures or scientific methods to guide own work and solve standard problems
•Responsible for: bulk buffer formulation, bead dropping using a beadulator, loading and unloading beads from the lyophilizer, sieving of beads, aliquoting and labeling
•Performs pH and Conductivity testing
•Perform accurate real time documentation to ensure right first time (RFT) operations
•Monitor equipment and inform leads or management of any issues
•Maintain laboratory housekeeping including reagent and equipment inventory levels
•Recognize issues and defects and escalate accordingly
•Recommend improvement ideas that will positively affect production efficiency, quality, and safety
•Any other tasks needed to support department

TRAINING RESPONSIBILITIES:
•Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:
Education and Experience:
•High School degree (or equivalent experience) with 1-2 years of related work experience OR
•AA or Technical Trade Degree with 0-1 years of work experience
Knowledge and skills:
•Must be able to follow cGMP and cGLPs, FDA and ISO standards
•Must be able to follow direction, able to understand SOPs and demonstrate understanding through speech and/or written form
•Proficiency in computer systems such as word, Excel, SAP and e-mail
•Understand how the assigned duties relate to others in the team and how the team integrates with others
Physical requirements/abilities:
•Must be able to lift 25 Lb Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
•Ability to transport heavy materials up to 400 Lb with the appropriate machine or equipment assist
•Ability to work in a controlled environment

PREFERRED REQUIREMENTS:
•Bachelor’s Degree in Life Sciences
•Experience working in a GMP/ISO manufacturing environment
•Experience using analytical scales, pipettes and working with hazardous chemicals
•Flexibility with the work schedule including modified shift times, overtime and weekends