Job Description

The Associate Process Group Chemist, in accordance with forecasted requirements and assignment, participates in the Chemistry Manufacturing department via:

• Manufacture products within QSR and ISO regulations
• Review/reconcile documents and work orders
• Support assigned projects with supervision
• Support departmental troubleshooting and process improvement teams
• Participate in product transfers
• May write/revise documentation with supervision
• May train lab technicians
• Display improving working knowledge of business processes as they relate to manufacturing
• Maintain daily adherence to Production goals relating to MUV/LUV, labor utilization, work order closure, and schedule adherence

ESSENTIAL FUNCTIONS:

• Manufactures (ie. Formulates bulks, and Quality Controls) products (ie. Lateral flow devices, controls/calibrators and microtitre systems) while adhering to regulatory requirements and business polices /procedures and schedules.
• Support departmental troubleshooting and process improvement teams. Support cross-functional projects and training.
• Reviews completed Device History Records and performs financial review of work orders. Reports on variances to supervisor.
• Carries out all duties in a professional manner and in compliance with established business practices.

INTERACTIONS:

• Associate Process Group Chemist may have interaction with the following groups/systems. Typically with supervision:
• Inventory control – obtain/return materials, resolve material variances related to work order usage
• LN – reconcile work orders, enter/check labor hours, check material availability, BOMs, general manufacturing queries, and close work orders. Prepare work order variance reports.
• Management – on a day to day basis as it relates to the tasks at hand, personnel issues
• Process engineering – technical troubleshooting, product transfers
• Production – coordinate optimization/matrix assembly
• Planning – report on schedule adherence
• Quality/Documentation – ECO’s, NCMR’s, deviations, validations, QTP's
• Facilities – request repairs/changes to facilities
• IT – request repairs
• Safety – training, compliance, may participate in safety committee, recommends safety and housekeeping improvements.
• Identify and articulate moderately complex problems.
• Make decisions related to tasks at hand.
• Work almost entirely self-directed within the scope of their job description.

EDUCATION, SKILLS & EXPERIENCE (indicate if required or preferred):

Education and Experience

• B.S./B.A. Life/Applied Sciences or equivalent experience and a preferred minimum of 6 months 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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