Quality System Document Management Specialist Contractor

Location
Cambridge, MA
Posted
Oct 04, 2021
Ref
2021-1120
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Overview

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-AllosteryPharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.

 

The Quality System Document Management Specialist will provide support to the process for creating, reviewing, approving, issuing, distributing, controlling, tracking, and maintaining controlled documentation used to support GxP QMS.  Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to internal procedures and applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet deadlines and to effectively prioritize based on criticality.

Responsibilities
  • Manage and maintain document control activities per SOP and regulatory requirements following Good Documentation Practices.
  • Develop and/or update workflows, policies, and procedures to govern archival and record retention processes
  • Identify and make recommendations for improvements to document management system.
  • Review companywide Quality Management Systems (QMS) SOPs, work instructions and accompanying forms.
  • Ensure all approved documents are maintained throughout the document lifecycle
  • Manage all controlled records both hard copy and electronic
  • Maintain record retention library and secure access
  • Help support maintenance of training curricula and related documents.
  • Identify and facilitate the resolution of any document control discrepancies or issues (escalate as necessary)
  • Master Document Log maintenance including document status and revision level
  • Obsolete documentation maintenance, preventing usage of outdated material
  • Assists in the documentation of key processes and departmental procedures.
  • Receives, classifies, files, audits, tracks, and maintains centralized documentation archiving system of controlled Quality System documents according to established procedures.
  • Responsible for file maintenance and record keeping; locates and retrieves file material upon request from record archiving location.
  • Assists in the preparation of legacy documents for migration into an electronic document control system.
  • Assist as required in regulatory inspection activities.
  • Effectively follows the company's standard operating procedures.
  • Understands the basic principles and concepts of the documentation lifecycle and associated electronic systems.
  • Partners with cross-functional associates to meet compliance requirements.
  • Guides change initiators in the development of accurate changes.
  • Ensures changes and documentations follow the company's policies and procedures.
  • Maintains filing of technical files, listings, certificates, licenses, etc.
  • Compiles data for the creation of metrics and reports for various departmental activities.
  • They establish individual training plans and ensures appropriate training is administered throughout the company
Qualifications

KNOWLEDGE/SKILLS/ABILITIES :

  • Initiative- self-starter who is pro-active by taking action to improve a situation without waiting for explicit instructions, recognizes and responds to opportunities in order to reach a goal, seeks new and improved techniques, solutions, and approaches to completing assignments 
  • Adaptability–remains fully functional by adapting to changing circumstances (environment, procedures, people)
  • Planning and organizing– proficient at determining goals and priorities and to assess the actions, time, and resources heeded to achieve those goals.
  • Multi-tasking- effectively handles multiple tasks in a changing environment
  • Communication skills– expresses oneself clearly and effectively when speaking and/or writing to individuals or groups, listens attentively, ensures that information is understood by all parties, shares information in a timely manner using the most appropriate method, presents well-organized information in a group setting
  • Fostering teamwork and collaboration- collaborative style – advocating a positive team concept to resolve problems and achieve optimal results
  • Attention to detail– proficient at processing detailed information effectively and consistently
  • Follow up– takes appropriate action to ensure a task, activity, or function has been completed
  • Technical skills- must be proficient-to advanced user of Microsoft Office 365/Suite products such as Word, Excel, PowerPoint, Outlook, and SharePoint

 

EDUCATION AND EXPERIENCE

  • Bachelor’s degree and 3 – 5 years’ experience in a similar role
  • Technical Writing /Document Control experience preferred.
  • Training experience
  • Experience in a regulated environment (medical device or pharmaceutical) is preferred
  • Tenacious attention to detail and consistency is required
  • Excellent communication and interpersonal skills working within all levels of the organization required
  • Working knowledge of Microsoft office tools (Word, Excel, Outlook, and PowerPoint)

 

Work Environment:

This job operates in a professional office environment. This role routinely usues standard office equipment.

 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

 

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

 

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.