Bulk Reagent Tech Jidoka Factory

POSITION SUMMARY:
Mid-level position responsible for supporting the Bulk Buffer production laboratory 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 analytical skills or scientific methods or operational processes to perform activities with a moderate degree of supervision. The Newark Jidoka factory is a 24/7 operation and this position reports to the Bulk Reagent Manager.

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

Recognizes and solves typical problems that can occur in own work area without supervisory approval; evaluates and selects solutions from established operating procedures and/or scientific methods

Responsible for bulk buffer formulation

Performs pH testing

Perform accurate real time documentation to ensure right first time (RFT) operations

Perform verification and review of peer activities

Train others on lab responsibilities

Monitor equipment and inform leads or management of any issues

Maintain laboratory housekeeping including reagent and equipment inventory levels

Recognize issues and defects and complete necessary documentation and escalate accordingly

Recommend and implement improvement ideas in the lab that will positively affect production efficiency, Quality and Safety

Assist other department in qualification of new methods and instruments

Trouble shoot equipment and assay failures

Suggest and assist in SOP revisions

Ability to perform in a fast-paced, goal oriented and time-sensitive environment.

Able to work independently and complete basic problem solving

Other duties as assigned by the manager and may be asked to be included in quality activities and employee activity teams.

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

MINIMUM REQUIREMENTS:Education and Experience (in years):
High School degree (or equivalent experience) with 4-6 years of related work experience OR

AA or Technical Trade Degree with 2-4 years of related 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

Has good understanding of how the team integrates with others

Applies experience and skills to complete assigned work within area of expertise

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 2000 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

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.