Associate Process Group Chemist

Title: Associate Process Group Chemist
Location: Carlsbad CA 92008
Duration: 9 Months

Summary of Position:
The Associate 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 supervision, participates in product transfers, supports departmental troubleshooting and process improvement teams, and displays an improving working knowledge of business processes as they relate to manufacturing.


Essential Functions:

• 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
• Supports departmental troubleshooting and process improvement teams
• Supports cross-functional projects and training.
• Reviews completed Device History Records, performs financial review of work orders, and reports on variances to supervisor
• Maintains daily adherence to Production goals relating to MUV/LUV, labor utilization, work order closure, and schedule adherence

Interactions:

• Associate Process Group Chemist may have interaction with the following groups/systems. Typically with supervision:
• Inventory Control - obtains/returns materials, resolve 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 - reports on schedule adherence
• Quality/Documentation - ECO's, NCMR's, deviations, validations, QTP's

Work Environment:
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.


Physical Demands:
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, Skills & Experience:

• B.S./B.A. Life/Applied Sciences or equivalent experience
• Preferred minimum of 6 months of related work experience in a GMP environment

Knowledge/Skills:

• Basic algebraic, statistical and mathematical skills
• General computer knowledge
• 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

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