Validation Analyst II
Title: Validation Analyst II – Data Integrity
Division / Dept.: Lab Support – IT
Location: Middleton, WI (Office Based)
Note: Full time, Benefits, Relocation Assistance Available
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
- Develops and maintains the GMP Laboratory strategy for Data Integrity.
- Evaluates proposed and existing software applications for Data Integrity compliance.
- Performs Data Integrity risk assessments of laboratory systems.
- Prioritizes risks and leads cross-functional Data Integrity initiatives involving IT, QA, and Laboratory personnel.
- Maintains currency with U.S. and European regulations related to Data Integrity.
- Prepares, maintains, and delivers presentation materials to client auditors and regulators for Data Integrity subject matter.
- Represents PPD in client and regulatory audits related to Data Integrity.
- Facilitates the completion of client questionnaires related to Data Integrity.
- Establishes a firm understanding of PPD IT Infrastructure, assesses proposed changes for Data Integrity implications, and recommends infrastructure changes to enhance Data Integrity.
To learn how PPD can advance your career, apply now!
Video links:
PPD LinkedIn Video Landing Page:
https://www.linkedin.com/showcase/ppd-laboratories/?feedView=videos
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Knowledge, Skills and Abilities:
- 5+ years working in a GMP regulated pharmaceutical environment.
- 3+ years of experience working with Information Technology and a fundamental understanding of IT concepts.
- 3+ years of experience in a computer systems validation or related quality assurance role.
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on data integrity.
- Ability to communicate effectively with all levels of the organization.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
PPD Benefits Overview:
PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.
Other benefits include:
- 401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.
- Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday and vacation sell back program.
- Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.
- Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.
- Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plans
- Community connections and activities including philanthropic engagement, volunteer service projects and more
- Other great options including pet insurance, legal and financial services plan, auto and home insurance discounts.
Below Is Listed The Working Environment/requirements For This Role
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary and/or standing for typical working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
