Lab Software Compliance Specialist

Peprotech, Inc

Peprotech, Inc

New Brunswick, NJ, USA
Posted on Tuesday, May 21, 2024

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the Thermo Fisher's Clinical Research Group team.

To learn how Thermo Fisher's Clinical Research Group can advance your career, apply now!

The main focus of the Validation Analyst (also referred to as a Scientific Software Compliance Specialist) will be to provide validation support for local and global regulated laboratory data systems and maintaining GMP documentation for these systems. This role will articulate and document the business needs and requirements, provide feedback during configuration, and conduct user testing of software features.

A day in the Life:

  • Apply FDA CFR 251 Prt 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes and computer software assurance.

  • Follow SOPs and industry standard processes.

  • Review validation deliverables including requirement and design specifications, summary reports, pre/post completed test scripts and procedures in support of the system and potentially generate these deliverables as needed.

  • Maintain close communication with collaborators and team members to keep informed of computerized system needs, impact on computer validation, project validation status, and other relevant issues.

  • Lead, assist and conduct planning, implementing, and documenting user requirements, risk assessments, software and UAT testing.

  • Assist in supporting operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.

  • Collaboration with various multi-functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate new software or enhancement opportunities, setup and qualify new systems or upgrade existing systems in the ASO testing laboratories.

  • Authoring and driving relevant sections of GMP software qualifications.

  • Ability to handle and organize the workload for multiple projects simultaneously.

  • Develop standard operating procedures which ensure the integrity of both the laboratory data collected and the systems used to collect the data.

  • Support the smooth adoption of the software and enhancements.

  • Acting as the support of the standalone applications and ensuring harmonized configuration, versions, and software usage across geographies.

Education and Experience:

  • Bachelor's degree in relevant field or equivalent

  • AND 3+ years of hands-on IT support experience, with at least 1 year in a lab environment with a clear understanding of GMP laboratory operations and testing

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Hands-on end user experience (i.e., system administrator or Super User on LIMS, Empower, ELN etc.)

  • Excellent oral and written communication skills in English. Once trained, can work independently on CSV, user requested upgrades/enhancements and continuous improvement projects with minimal oversight.

  • Ability to perform in a highly matrixed organization structure.

  • Possess Expertise on Good Documentation and Good Testing Practices and understanding of cGMPs and Computer System Validations.

  • Demonstrated experience installing, configuring, and supporting GMP systems and applications in lab environments. This includes instrument software applications.

  • Demonstrated creative and innovative solution with regards to compliance in CSV.

  • Experience with electronic document management systems (e.g., Veeva platform, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, ValGenesis, etc.)

  • Experience with one or more of the following: software testing and deployment, validation and UAT execution, and asset lifecycle management.

  • Knowledge of laboratory automation technologies such as standalone benchtop applications, statistical software (Slimstat or similar) and scientific data management systems (NuGenesis, MODA, or similar).

Working Environment:

Thermo Fisher Scientific Clinical Research Group 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.

  • As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Our 4i Values:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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