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Chemist at Apex Systems, Inc. in San Diego, CA

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Description

SUMMARY

Participates in the preparation of autoimmune diagnostic products, utilizing the technology platform, following established procedures. Major duties include bead and reagent preparation activities and the preparation of controls and conjugates for the product lines.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Prepares product bulks and solutions required for antigen coupling according to written manufacturing documents and schedules.
  • Researches and corrects problems with production according to established Standard Operating Procedures (SOPs) and procedures.
  • Assists with the evaluation of raw materials, in-process materials and finished reagents associated with products according to written procedures.
  • Prepares and performs validations for all equipment according to written protocols.
  • Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing, evaluation and development activities in accordance with Quality Systems Regulations (QSRs). Assists with the generation and implementation of Engineering Change Orders (ECOs) for manufacturing documents and SOPs.
  • Prepares, calibrates, operates and cleans equipment used in the manufacture of products according to written SOPs.
  • Investigates, analyzes and carries out corrective actions for product performance or manufacturing problems in conjunction with supervisor and the assistance of others.
  • Informs supervisor of laboratory equipment needs and other supplies required to avoid interruptions in production schedules. Informs supervisor of broken or deteriorating equipment.
  • Carries out all tasks required to improve product performance/quality and/or process efficiency for autoimmune diagnostic products as requested by supervisor.
  • Maintains work area and laboratory in a clean and orderly manner.
  • Follows established safety and environmental procedures. Reports all safety hazards immediately.

QUALIFICATIONS & EDUCATION

  • Bachelor's degree B.A. or B.S. or equivalent in the biological or related sciences with 1-2 years of laboratory experience
  • Working knowledge and/or laboratory skills in the area of solution preparation, immunochemistry conjugation techniques, computer operation procedures and laboratory equipment operation
  • Knowledge of QSR and Engineering Change Orders (ECOs) systems as they apply to diagnostics manufacturing
  • Ability to calculate figures and amounts such as concentrations, dilutions, proportions, percentages, volumes and common laboratory equations
  • Ability to read and interpret documents such as device history records, operating and maintenance instructions, scientific journal articles, safety rules and SOPs
  • Ability to write reports, SOPs, manufacturing documents, laboratory notebook entries and correspondence
  • Ability to speak effectively with co-workers and other employees of the organization

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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