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Laboratory Production Specialist

2 months ago

Rocklin, California, United States Randstad Life Sciences Full time
Job Overview

Contract Type: 1 Year

Location: Rocklin, CA

Pay Rate: $20-25/hr

Position Objective:

  • The Laboratory Production Specialist in Manufacturing Histology will execute laboratory functions within the production facility, which includes slide production and packaging tasks, while assisting in processes necessary for block qualification. This role adheres to the manufacturing schedule to fulfill required activities in accordance with standard operating procedures, utilizing fundamental laboratory techniques, calculations, material measurements, and necessary record-keeping.

Key Responsibilities:

  • Produce and package items in compliance with SOPs
  • Utilize local ERP systems for precise documentation of manufacturing workflows
  • Manage inventory levels in the work area as needed
  • Ensure laboratory cleanliness and adherence to cGMP standards
  • Conduct microtomy, IHC staining, and troubleshoot issues
  • Maintain accurate records and update spreadsheets regularly
  • Report any non-conforming products to management and engage in the investigation process
  • Achieve productivity benchmarks while enhancing efficiency without compromising quality and safety
  • Identify opportunities for quality improvement
  • Exhibit precision and thoroughness in all tasks
  • Effectively manage time and priorities to meet deadlines
  • Troubleshoot equipment malfunctions
  • Participate in various projects aimed at improving efficiency or compliance
  • Adhere to regulatory and standard requirements relevant to the site, including MDSAP, ISO 13485, IVDR, and the site Quality Manual.
  • Perform additional duties as assigned or required by the organization

Qualifications:

  • Associate's or Bachelor's degree in biological sciences or biochemistry with a minimum of 1 year of production experience
  • Familiarity with FDA QSRs and ISO 13485 or other related industry standards is preferred; experience with SAP or similar ERP systems is highly desirable
  • Prior experience in an FDA-regulated biotechnology or pharmaceutical setting is strongly preferred

Skills and Competencies:

  • Proficient computer skills, including MS Office
  • Strong organizational skills and attention to detail
  • Effective verbal and written communication skills, including the ability to produce clear, concise reports and accurately complete batch records
  • Knowledge of SAP NEXT is strongly preferred

Physical and Environmental Requirements:

  • Vision: Must meet vision requirements as per standard occupational guidelines.
  • Lifting and Moving: Ability to lift up to 25 lbs. daily
  • Pushing: Occasionally push up to twenty-five (25) pounds unassisted
  • Sitting: Frequently as required by the process
  • Standing: Frequently as required by the process
  • Climbing: Occasionally, using a ladder or step ladder as needed
  • Kneeling: Occasionally as required by the process
  • Stooping: Occasionally as required by the process
  • Full Use: Occasionally as required by the process
  • Simultaneous: Occasionally as required by the process
  • Communication: Requires both written and oral communication skills to interact with others and receive instructions in English.
  • Other: Involves repetitive motion with hands, fine manipulation for tasks such as keyboard use or pipetting; includes reaching with hands and arms; occasional standing and lifting; seldom involves stooping or crouching.

Working Conditions:

  • Most work will occur in a production/manufacturing or laboratory environment. The ability to clearly and comfortably view, interpret, and process information via a computer monitor for extended periods during normal working hours is essential. The capacity to work amidst moderate background noise is also required.
Company Overview

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