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Reagent Manufacturing Associate II

Job Title:    Reagent Manufacturing Associate II
Reports To:   Manager, Production
FLSA Class:   Non-exempt
 
Position Summary/Objective:
Responsible for performing a variety of manufacturing and laboratory tasks while following established processes and procedures independently with limited supervision daily, specific supervision on new tasks. Works on assignments that are moderately complex and where judgment is required in resolving problems and making routine recommendations. Performs visual and functional in-process inspection to assure products meet specifications and quality standards. Maintains laboratory equipment and inventory levels of laboratory supplies. May be responsible for limited troubleshooting and calibration of instruments, writing manufacture batch records and setting up bill of materials.

This role works independently with general supervision and training on new tasks or processes. Helps demonstrate proper technique and provides advice on processes for entry level Reagent Manufacturing Associates.

The Reagent Manufacturing Associate II an on-site role located in San Jose, CA.

Essential Functions:
  • Responsible for manufacturing assigned products which will include formulations, aseptic aliquoting, product labeling and operating production equipment while following established processes and procedures.
  • Responsible for following production procedures to optimize manufacturing processes and regulatory requirements.
  • Performs in-process inspections to assure products meet specifications and quality standards.
  • May write Manufacturing Batch Records, Bill of Materials for products.
  • Maintains manufacturing documentation in accordance with quality management system.
  • Maintains lab environment to comply with regulatory requirements, standard operating procedures and good laboratory practices.
  • Comply with and support EH&S and quality management system policies and procedures.
  • Maintains laboratory equipment by following good laboratory practices.
  • Maintains inventory accuracy through proper processing of product job orders and cycle count activities.
  • May be responsible for communicating with suppliers for material orders.
  • May suggest ideas for new methods and technologies to enhance production operations.
  • May assist in QC laboratory functions such as set-up, operating and maintaining laboratory equipment following standard procedures and methods.
  • May perform functional test inspections to support quality control group.
  • May be involved in distribution processes such as receiving purchased parts and shipping products or components.
  • Helps demonstrate proper technique and provides advice on processes for entry level employees.
  • This position does not have supervisory responsibilities.


Education/Certification, Experience, and Competencies:
  • BS/BA degree in a scientific discipline, such as molecular biology, biochemistry or chemistry is required.
  • Minimum of 2-4 years’ experience in a manufacturing environment including familiarity with instrumentation and chemical handling and storage. Experience handling bio-hazardous materials.
  • Experience with basics of one of the scientific disciplines noted and a firm background in quantitative methods is required.
  • Strong documentation skills and attention to detail is necessary.
  • Good communication skills and ability to coordinate work with other team members.
  • Ability to set up, observe and assess results of experiments is required.
  • Ability to troubleshoot and problem solve to recommend corrective action.

Physical Demands/Work Environment:
  • Maintain a safe, clean and productive work environment.
  • Ability to comply with applicable personal protection equipment.
  • Ability to perform repetitive motion tasks using upper body and while sitting or standing in one place for periods of 1-3 hours of time.
  • While performing the duties of this job, the employee may be required to lift, push, or pull up to 40 lbs. and up to 170 lbs. with assistance or use of tools.


Position Type/Work Hours:
This is a nonexempt, hourly position (part-time or full-time); Monday through Friday during standard
business times with flexibility required to work overtime as needed.


AAP/EEO Statement:
Takara Bio USA, Inc. does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Disclaimer:
Please note 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.