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Quality Control Scientist

2 months ago

Marlborough, United States Randstad Life Sciences US Full time

6 Month Contract

Marlbrough, MA - Must be local

PR: $39-44/hour


Job Summary

The QC Scientist I Analytical will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.

This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs.


Job Responsibilities

The QC Scientist I Analytical will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.

  • Develop/author/revise technical reports and laboratory procedures (SOPs, methods) as well as LIMS builds
  • Execute and troubleshoot release, stability and in-process testing in support of production activities
  • Design and perform testing in support of method transfer/validation/qualification/verification
  • Review/authorize data and perform analysis and interpretation of test results and trends
  • Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
  • Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
  • Support and mentor junior team members
  • Collaborate with other network sites to share best practices
  • Other duties as required


Education & Qualifications

Required

  • B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role
  • Prior laboratory hands-on experience with a variety of analytical techniques such as HPLC utilizing a CDAS application such as Empower, CE, DLS, UV-VIS spectroscopy, sub-visible particulate analysis, pH, osmolality and other chromatographic and physiochemical techniques.
  • Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data
  • Experience using LIMS as an end user; Excellent technical writing and verbal communication skills
  • Must be capable of observing and adhering to lab safety standards and procedures
  • Successfully performs work independently with minimal instructions
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
  • Highly self-motivated and goal oriented
  • Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned

Preferred

  • Experience in a small company and high growth, fast-paced environment
  • Experience in qualification of analytical equipment, including those with computerized systems
  • Experience in method validation/qualification/verification/transfer

Working Conditions

  • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
  • This is an on-site role working in a cGMP regulated manufacturing facility.
  • On occasion, this role may travel to other manufacturing facilities (0-5%)