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QC Technical Writer (Contract)

Company: Revance
Location: Newark
Posted on: June 8, 2021

Job Description:

Position Summary

The Technical Writer provides technical writing and supports authoring of quality system records such as laboratory investigations, deviations, CAPAs and change controls. Conduct investigations of laboratory investigations and deviations. Monitor completion of the quality events within Quality Control and provide escalation to management as needed. Perform metrics for laboratory investigations and laboratory operation parameters as appropriate. Author and/or revise other documents such as SOPs, methods, work instructions, protocols and reports.

Essential Duties/Responsibilities

  • Provides technical writing for QC organization
  • Responsible for authoring laboratory investigations, deviations, CAPAs and change controls.
  • Conduct investigations thoroughly to identify all impact to patients, product quality, data integrity, validated state, and regulatory compliance
  • Conduct root cause analysis to identify all contributing and potentially contributing factors related to the investigation
  • Perform risk analysis as needed to determine likelihood and severity of recurrence
  • Address impact to systems, processes, product, and any regulatory requirements
  • Identify and develop relevant and effective CAPAs
  • Monitor completion of lab investigations, deviations, and CAPAs
  • Prioritize and organize laboratory investigations and deviations to ensure timely completion
  • Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines
  • Perform metrics as appropriate for laboratory investigations and laboratory operation parameters

Education

  • Requires a Bachelor of Science in Biochemistry, Biology or a related pharmaceutical-biotechnology discipline. Master of Science in related field is highly desired.

Experience

  • A minimum 5 years work experience within a GMP environment working with small and/or large molecules.
  • Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC/UPLC chromatography, including Waters Empower software is required.
  • Solid technical training and troubleshooting experiences are essential.
  • Strong understanding of data integrity principles within a GMP environment

Knowledge, Skills and Abilities

  • Knowledge of cGMP requirements and ICH guidelines.
  • Proficient written and verbal communication skills are required.
  • Proficient in the use of Microsoft Word and Excel
  • Excellent interpersonal and communication skills in a team-oriented environment are required.
  • Strong critical thinking and problem-solving skills.
  • Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Keywords: Revance, Newark , QC Technical Writer (Contract), Other , Newark, California

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