Lonza · 2 days ago
QA Deviation Specialist
Tampa, FL
Full-time
Onsite
Mid Level
3+ years expLonza is a company dedicated to improving lives through innovative solutions in life sciences. The QA Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations and complaints in accordance with company policies and regulatory requirements, while collaborating with various departments to ensure product quality and compliance.
BiotechnologyLife SciencePharmaceutical
Responsibilities
Facilitate and lead assigned investigations involving multiple investigation areas
Work with various departments, including manufacturing, packaging, quality control, maintenance, engineering, and supply chain, to conduct investigations, determine root cause and implement improvements
Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause
Analyze deviation trends and provide insights for continuous improvement initiatives
Ensure that investigations and reports are completed and closed within specified timelines
Assess deviation potential impact to product quality for root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity
Determine the appropriate actions needed to prevent the recurrence of the event and define the criteria for evaluating the CAPA's effectiveness
Review, update and approve Standard Operating Procedures (SOPs) and other company documents
Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance
Prepare and present deviation reports to management and regulatory authorities as the need arises
Ensure that documentation is completed following Good Documentation Practices (GDP)
Support regulatory inspections, internal audits, and customer audits as required
Perform additional job-related assignments as requested by management
Qualification
Required
Bachelor's degree in science, preferably chemistry
3 years of experience in quality assurance, deviation management, or a related role in [industry, e.g., pharmaceuticals, manufacturing, etc.]
Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
10001+ employees
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 CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
2026-01-07
2026-01-05
Company data provided by crunchbase