FSP-Lab Data Associate II

Work Schedule

Environmental Conditions

Job Description

Thermo Fishers 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 demonstrate 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.

Lab Data Associate II:

Below are the services PPD are to perform (not an all-inclusive list and applicable to each FSP FTE as

appropriate to the FSP FTE job function):

• Uploading internal documents and/or 3rd party data into electronic document management system (such as Veeva QualityDocs)

• Formatting documents per relevant SOP and/or job aid

• Circulating documents for approval and follow through to ensure timely approval

• Assist the Manager with tracking and following up with the implementation of control procedures job aids and other documentation necessary for the client to operate CAPAs risks registers etc

• Assesses procedures for accuracy simplicity and practicality and influences changes as appropriate

• Assists/participates in preparation for and support of regulatory agency inspections corporate and customer audits.

• Builds and maintains good working relationships with internal and external partners

• Performs data verification as necessary

• Manages issues and risks identified in area of responsibility

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to atleast 6 years).

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:

Ability to focus on details.

Critical thinking skills to identify and solve problems.

Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.

Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner.

Exhibits high initiative strong drive and follow-through.

At least 1 year of GMP experience is strongly preferred

Knowledge of and ability to use electronic Learning Management system (such as MyLearning) electronic document management systems (Veeva)

Knowledge of GMP Good Documentation Practices and pharmaceutical manufacturing

Ability to manage databases of document owners reviewers approvers authors and trending data

Ability to coordinate documentation projects involving multiple documents and external partners

Ability to influence motivate and gain commitment without direct authority

Works well with peers and all levels of management

Displays strong leadership facilitation teamwork networking presentation and planning skills

Excellent verbal and written communication and interpersonal skills

Exhibits high initiative strong drive and follow-through.

Effective organizational skills

Good computer skills

Strong attention to detail and problem solving skills

Good written and verbal communication skills

Ability to effectively conduct oral presentations

Demonstrated experience in identification and resolution of technical problems in a professional environment

Ability to attain maintain and apply a working knowledge of applicable procedural documents

Demonstrated positive attitude enthusiasm toward work and the ability to work well with others