QC Technical Writer (Contract)
Posted on: June 8, 2021
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.
- 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
- 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
- Identify and develop relevant and effective CAPAs
- Monitor completion of lab investigations, deviations, and
- 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
- Requires a Bachelor of Science in Biochemistry, Biology or a
related pharmaceutical-biotechnology discipline. Master of Science
in related field is highly desired.
- 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
- Strong understanding of data integrity principles within a GMP
Knowledge, Skills and Abilities
- Knowledge of cGMP requirements and ICH guidelines.
- Proficient written and verbal communication skills are
- 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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