Specialist, TMF Quality And Records Management
770 Lindaro Street San Rafael, CA 94901
Bayside Solutions is seeking a Specialist, TMF Quality And Records Management to be part of our client’ s team in Marin County. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Specialist, TMF Quality And Records Management
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Specialist is responsible for actively supporting the Development Sciences Quality organization in the areas of: Quality Operations, Controlled Document Management, or Trial Master File (TMF) Quality and Records Management. For example, the Specialist may support the management and tracking of SOP deviations, corrective and preventative action (CAPA) plans, and data integrity plans.
- The Specialist may be involved in supporting document control systems and processes, or coordinating inspection and audit responses and associated record-keeping.
- Individuals in this role are expected to demonstrate good foundational Communication, Problem Solving, Planning, Prioritization and Organization, Proactivity, and Teamwork skills in order to quickly integrate into the client’ s team-based, cross-functional culture. This includes:
- Sharing ideas and work product with competence in a clear, concise, and timely way.
- Effectively facilitating small functional meetings.
- Adeptly identifying critical path tasks and consistently delivering on time and as expected.
- Developing and maintaining strong working relationships.
- Modeling a fair, transparent and collaborative approach to work execution.
- The Specialist will also focus on developing skills in the Leadership and Influencing and Persuasion competency areas.
- The Specialist is expected to demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management. Skills should include:
- An understanding of key regulatory agencies and regulatory inspection processes.
- An understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV).
- An understanding of GxP principles, their importance, and how they apply to operational activities currently being performed.
- The Specialist has foundational skills in Planning, Teamwork, Proactivity, Communication, and Problem Solving.
- The specialist should exhibit foundational skills in Regulations and Good Practices and Quality Management while developing technical skills in Process Analysis and Change Management.
- TMF Management.
- Facilitate the creation of the enterprise and study specific TMF management tools.
- Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level.
- Coordinate creation of the TMF filing locations within the clients based on the study specific TMF Content List.
- Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF.
- Facilitate the review and submission of TMF records to Records Management personnel.
- TMF-Related Collaboration & Support.
- Support the coordination of the transfer of study-specific trial master files from the CRO.
- Participate in Study Team meetings and provide/present regular TMF metrics updates.
- Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team.
- BA/BS in life sciences or technical area; experience in lieu of education may be considered.
- 2+ years of relevant pharmaceutical industry experience.
- Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus.
- May frequently be required to sit and talk or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.