Laboratory Analyst

Job Description

Job Summary:

• 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.

Duties and 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.

Education and Experience:

• Bachelor’s Degree in Life Sciences.
• 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.
• Experience working in a GMP/ISO manufacturing environment.
• Experience using analytical scales, pipettes and working with hazardous chemicals.

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.

Schedule Notes:

• Flexibility with the work schedule including modified shift times, overtime and weekends.