About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
The BioLife Data and Documentation Control (DDC) team is responsible for ensuring documents and records are managed within compliance to applicable regulations and company procedures.
They oversee these processes for BioLife U.S. Centers and Headquarters personnel.
They are responsible for the continual improvement of these processes and work with key stakeholders across the company, including:Â BioLife operations, BioLife Quality, BioLife project teams, BioLife Training, global Takeda process owners, global teams, global communities of practice, BioLife service providers and suppliers.
Oversight of document and record lifecycle activities (creation, revision, periodic review, storage and destruction)
Qualify and manage approved service providers (including payments for services and issue resolution)
Provide training, coaching and access to the global document management system
Establish and enforce processes to comply with data integrity requirements for documents and records
Manage the Signature Log and Delegation processes
Own and manage the protocol and white paper processes
Oversight of process change controls
Lead and support BioLife growth and improvement initiatives
Subject matter expert for data and documentation management activities for regulatory and internal inspections
Subject matter expert for data and documentation management activities related issues and mitigations
Â Procure, assess, test, and provide insight on new technologies being pursued by BioLife
Â Monitor and report on performance execution of data and document control processes
Â Assist with Takeda Integration activities, and provide cross functional support for NAT/BOL process, Donor Reinstatement documentation, New Center Installation validations, etc.
DIMENSIONS AND ASPECTS
Ability to drive decisions through influence
Strong communication skills (written and oral)
Ability to manage, prioritize and deliver on core responsibilities
Decision-making and Autonomy
Ability to identify and resolve problems as they arise
Ability to understand the risks and benefits surrounding decisions
Customer focus â willingness to help, respectful, prompt and accountable
Partners with BioLife Quality and Center Operations
Open to new ideas
Confidence in challenging the status quo
Ability to thrive in a dynamic setting
Ability to break down complex situations into manageable pieces
Ability to understand upstream and downstream impact of decisions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
5 + years of experience with data management/documentation systems or equivalent Change Control
GED or Associates Degree
Experience within a regulated industry and knowledge of Quality business systems
Understanding of plasma collection business and associated regulations
Strong knowledge of GMP's
Proficient in Microsoft tools:Â Teams, Excel, Word, PowerPoint, and SharePoint
Experience in technical and procedure writing & leading cross-functional teams
Ability to handle multiple projects at one time with strong attention to detail
Internal Number: R0031962
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.