Validation Analyst

Regulatory Toolkit; Town of Middleton (WI); Hybrid; USD 65,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific's PPD Laboratory Services is seeking a QA/Validation Specialist to provide basic business/system support of software systems and laboratory instrumentation, participate in PQ validation, and facilitate system upgrades.

You will prepare validation plans, test cases, execute tests, review change controls, and ensure PV meets business needs while complying with SOPs and regulatory requirements. Hybrid role based in Middleton, WI with onsite onboarding.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of experience in a related role or equivalent
• Equivalency may be considered with relevant education, training or experience

Responsibilities

• Participates as a validation representative at project team meetings and completes assigned action items; provides direction for future releases to software systems; reviews and approves/rejects change requests; communicates with project team members and management.
• Provides validation support for new releases and modifications to applications throughout the SDLC; prepares validation plans, test cases and validation summary reports; executes test cases.
• Reviews and approves all change controls for validated systems per SOP; reviews PQ and change control documentation with leadership per SOP.
• Ensures test scripts cover functional requirements and demonstrate that the application meets business expectations.
• Executes test scripts to provide evidence that systems perform correctly; creates/updates data in testing environments; works with leadership to address PQ issues from audits.
• Manages assignments to meet deadlines and deliver high-quality work; adheres to contractual obligations and SOPs.
• Participates in identifying user requirements and system design; assists in preparing and reviewing system documents such as requirements and design specs.

Skills

Client-focused

Interpersonal skills

Communication skills

Attention to detail

Problem solving

Time management

SDLC knowledge

GCPs knowledge

Teach others

Team collaboration

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Microsoft Project

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is a hybrid position basedatour 8551 Research Way location in Middleton, WI. This position is typically working onsite during initial onboarding and training, typically a few weeks. This position is required to work onsite at the above location for business needs due to training, vendor meetings, onsite validation activities etc. The schedule for remote vs. onsite days will vary based on business needs. We welcome applicants from all locations within the US. Please note that relocationassistanceis not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check, whichincludes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems.

A Day in the Life:

• Participates as a validation representative at project team meetings and completes assigned action items. Provides direction for future releases to software systems; reviews and approves/rejects change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints.

• Provides validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports, and executes test cases.

• Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.

• Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.

• Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits.

• Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.

• Participates in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation.

Keys to Success:

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 2+ years).

Insomecases,anequivalency,consisting of acombinationof appropriateeducation, training and/or directlyrelatedexperience, will beconsidered sufficient for anindividualtomeetthe requirements oftherole.

Knowledge, Skills,andAbilities:

• Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others

• Strong attention to details and problem-solving skills

• Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction

• Positive attitude, enthusiasm toward work, and the ability to work well with others

• Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines

• Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)

• Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced

• Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps

• Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures

• Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team

Working Conditions and Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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.