QC TECHNICIAN II

Company: Fresenius Kabi
Location: Wilson
Posted on: November 22, 2021

Job Description:

Job SummaryResponsibilities include routine testing to support product release, raw material release, and cleaning verification. The technician will rely on experience and judgment in order to plan and accomplish goals.ResponsibilitiesJob DescriptionPRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Sampling of APIs, excipients, and components
• Routine testing of samples supporting incoming raw materials, in-process production, finished product, stability lots, validation, and product development
• Measure components with rulers and calipers
• Review specifications and drawings to ascertain sample quantities and testing to perform
• Utilize LIMS and ExcelSafe for data entry and test recording
• Perform instrument calibration and preventive maintenance
• Maintain the data archives and samples
• Logging and tracking of samples
• Documents and reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements
• Prioritize sampling/testing to meet turnaround timing
• Assumes other duties as assigned by area management
• Receives manufacturing and stability samples for chemistry and microbiology testing.
• Maintains controlled drug product inventory and actively participates in reconciliation process.
• Maintains chemical inventory, logs in new chemicals and disposes of expired chemicals as necessary.REQUIREMENTS
  • BS degree in Chemistry or related field.
  • Associate degree in chemical/physical or biological sciences with 1-2 years of related experience
  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, USP/NF
  • Excellent verbal and written communication, organization, prioritization, displays sound judgment, problem-solving, interpersonal and analytical skills
  • Ability to work in a fast-paced environment performing routine tasks on a daily basis
  • Ability to lift 25 to 50 lbs.
  • Electronic review of label copy (software for verification)
  • Ability to visualize measurements to 0.5mm
  • Use of compression/tension bench.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.

Keywords: Fresenius Kabi, Wilson , QC TECHNICIAN II, Professions , Wilson, North Carolina