Quality Control

1 month ago

Norwood, United States Randstad Life Sciences Full time
Job DescriptionJob Description

Immediate opportunity for a Quality Control (QC) Analyst to support cGMP QC testing for raw materials, drug substances, and finished products at one of our major clients' manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards.

Schedule/Shift: 1st shift, Mon.-Fri.

Position Type: Contract role for 6 mos.; extension possible

Essential Duties and Responsibilities:

  • Execute QC molecular biology and Bioassay methods (e.g. qPCR, sequencing, protein expression (cell based and cell free)
  • Assist in troubleshooting equipment and assay issues.
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc.
  • Establish and maintain a safe laboratory working environment.
  • Write, revise, and maintain SOPs, protocols, and reports.
  • Support training as assigned.
  • Assist in execution of Quality records (i.e. investigations, change controls, CAPAs)
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Additional duties may be assigned.

Qualifications:

  • Bachelor's degree (BS) in Molecular and Cellular Biology, Biological Sciences or related field
  • Three (3) or more years' experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell based assays
  • Method development / qualification experience with molecular biology, cell-based assays, or protein analysis methods.
  • Experience with some of the following techniques: qPCR, protein expression, sequencing, cell passaging, cell culture
  • Trained in aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
  • Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
  • Experience with laboratory equipment calibration and maintenance.
  • Ability to work effectively in a fast-paced, cross-functional matrix environment.
  • Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industryCompany DescriptionA great company doing groundbreaking and important work with a great reputation in the industry

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