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Process Group Chemist

Carlsbad, CA 92008

Posted: 12/27/2022 Employment Type: Direct Placement Category: Chemists and Materials Scientists Job Number: 95830

Job Description

SALARY: $62,000 - $66,000

The Process Group Chemist, in accordance with forecasted requirements, participates in the manufacture of products within QSR and ISO regulations. This position reviews and reconciles documents and work orders, supports assigned projects with minimal supervision, participates in product transfers, leads or supports departmental troubleshooting and process improvement teams, and displays an improving working knowledge of business processes as they relate to manufacturing.

  • Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules
  • Provides training to chemistry staff on Manufacturing Instructions and Standard Operating Procedures (SOP)
  • Displays leadership by assessing issues affecting departmental performance, Quality standards, and product quality then communicates to management and initiates appropriate corrective action
  • Supports departmental troubleshooting, cross-functional projects and process improvement teams
  • Reviews completed Device History Records and performs financial reviews of work orders. Initiates appropriate corrective action through Engineering Change Orders (ECO)
  • Maintains daily adherence to Production goals relating to MUV/LUV, labor utilization, work order closure, and schedule adherence
  • Works with the planners and develops weekly schedule

The Process Group Chemist will interact with the following groups/systems:
  • Inventory Control – obtains/returns materials, resolves material variances related to work order usage
  • LN – reconciles work orders, enters/checks labor hours, checks material availability, BOMs, general manufacturing queries, and closes work orders; prepares work order variance reports
  • Process Engineering – technical troubleshooting, product transfers
  • Production – coordinates optimization/matrix assembly
  • Planning – works with supervisor and planners to develop weekly schedule and report on schedule adherence
  • R&D - participate in product transfers, validations, resolution of technical issues
  • Quality/Documentation – ECO’s, NCMR’s, deviations, validations, QTP's, investigation reports

The work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

Education and Experience
  • B.S./B.A. Life/Applied Sciences or equivalent experience
  • Preferred minimum of 3-4 years of related work experience in a GMP environment

  • Basic algebraic, statistical and mathematical skills
  • General computer knowledge and experience with EXCEL or equivalent programs
  • Proficient in data analysis, data summary, and presentation
  • Good organizational skills
  • Laboratory skills, such as protein purification, antibody conjugation, solution preparation
  • ELISA experience, assay development skills, etc.
  • Good verbal and written communication skills
  • Good interpersonal skills
  • Knowledge of QSR’s and ISO 9001
  • Knowledge of experimental design
  • Basic Chemistry or Biochemistry

We are proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/ Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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