Quality Control Analyst (Tech Writer)
Company: Actalent
Location: Newark
Posted on: August 4, 2022
|
|
Job Description:
Description: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.Skills:sop, writing skills,
investigation and analysis, GMP, biologics, deviation, CAPA,
quality controlAdditional Skills & Qualifications:Preferred
Experience:--- A minimum 2-5 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.---
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 parametersExperience
Level:Entry Level About Actalent: Actalent connects passion with
purpose. Our scalable talent solutions and services capabilities
drive value and results and provide the expertise to help our
customers achieve more. Every day, our experts around the globe are
making an impact. We're supporting critical initiatives in
engineering and sciences that advance how companies serve the
world. Actalent promotes consultant care and engagement through
experiences that enable continuous development. Our people are the
difference. Actalent is an operating company of Allegis Group, the
global leader in talent solutions.The company is an equal
opportunity employer and will consider all applications without
regards to race, sex, age, color, religion, national origin,
veteran status, disability, sexual orientation, gender identity,
genetic information or any characteristic protected by law.
Keywords: Actalent, Newark , Quality Control Analyst (Tech Writer), Professions , Newark, California
Click
here to apply!
|