Deviation Investigation Writer Level 2 jobs in United States
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Lonza · 19 hours ago

Deviation Investigation Writer Level 2

positionHouston, TX
timeFull-time
remoteOnsite
seniorityMid Level

Lonza is a global leader in life sciences manufacturing, dedicated to producing the medicines of tomorrow. They are seeking a Deviation Investigation Writer Level 2 responsible for initiating and investigating process deviations, identifying root causes, and implementing corrective actions to ensure product quality.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Technical writing for the educated but uninformed reader, translating difficult and complex scientific events into a brief and cohesive report as a finished product
Gathering Data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact to SISQP, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing
Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner
Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and resolution
Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews
Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward
Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty

Qualification

Root Cause AnalysisCGMP quality systemsTechnical writingMicrosoft Office SuiteData gatheringInterviewingConflict resolutionProblem solving

Required

Ability to engage and interview co-workers to obtain relevant information pertaining to investigations
Familiarity with cGMP quality systems
Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records)
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint)

Benefits

Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).

Company

Lonza

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Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
dateFounded in 1897
location
Basel, Basel-Stadt, CHE
people-size10001+ employees
web-link
http://www.lonza.com

H1B Sponsorship

Lonza has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$444.8M
2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO

Leadership Team

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Wolfgang Wienand
Chief Executive Officer
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Alfons Ehinger
Founder

Recent News

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Company data provided by crunchbase