Quality Scientist

2 weeks ago

Billerica, United States Randstad Life Sciences US Full time

A major company advancing patient care by learning, adapting and making advancements across the healthcare spectrum. It begins with a passion for innovation. For making a difference. The company is continuing to forge ahead with new solutions to new problems—always knowing that someone’s health is in our hands.

Job Summary

Provide scientific support and apply technical expertise to the QC Tech Group laboratory department as well as other functional areas within the organization to ensure quality, compliance and efficiency in QC laboratory performance.

Job Responsibilities

  • Subject matter expertise in equipment qualifications and tech transfer projects.
  • Highly experienced in a QC laboratory setting including use of HPLC/GCs and analysis of data.
  • Familiar with Empower, Empower-LIMS integration, LIMS master data creation.
  • The Tech Group is responsible for trending QC lab results, instrument and method periodic assessments, compendia review and special projects.
  • Experienced in analyzing data and developing technical reports to support project plans.
  • Write and execute protocols/reports for instrument qualifications, procedural verifications, and process changes. May be responsible for maintenance of equipment. Perform periodic QVAs (quality validation assessments).
  • Perform non-routine/advanced lab testing in accordance with SOPs and cGMP guidelines. Perform verification and approval of data to ensure accuracy.
  • Assist with inspection readiness activities and act as department SME during audits/regulatory inspections, assist with responses.
  • Utilize a range of electronic systems such as LIMS, CDS-Empower, document/equipment management software, and SAP(if applicable). Perform functions for laboratory software (if applicable).
  • Review and act as document owner for procedure changes; initiate change controls, CAPAs, and other quality system requirements, as required.
  • Supports the successful completion of major programs and projects. Demonstrates flexibility to handle changing priorities without impact to other projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
  • Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgement, overall adequacy and accuracy.
  • Team player who can work with quality and attention to detail. Effectively and efficiently participate in assigned tasks in a quality manner. Strong communication skills both oral and written, professional conduct. Solid interpersonal skills, ability to interact with a diverse group of individuals at various levels. Interacts with internal and/or external personnel on technical matters which may require coordination between organizations.
  • Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards through partnership with Environment Health and Safety resources. Work with potentially hazardous chemical, radiological and/or biological materials on a regular basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
  • Promote and actively demonstrate the values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.

Education & Qualifications

  • Typically requires 4-8 years with a BS (0-2 years with an MS) or equivalent combination of education and experience, of previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Advanced degree preferred.
  • Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions. Some non-routine travel may be required.
  • Work with (or in proximity to) potentially hazardous chemical materials and must be able to lift/move materials, e.g. 25 lb. HPLC waste containers, gas cylinders, and chemicals.

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