Bristol-Myers Squibb Company

Analytical Documentation & Change Control Specialist

Location
Devens, MA, US
Posted
Sep 13, 2018
Ref
R1509352
Required Education
Bachelors Degree
Position Type
Full time
The primary role is to coordinate and support documentation activities and analytical change control for biologics and pharma products, ensuring compliance with cGMP requirements as part of the Analytical Science and Testing (AS&T) team in the Global Testing Standards department.

Duties/Responsibilities:

  • Coordinate compilation, formatting, and approval of biologics clinical and commercial specifications.
  • Coordinate documentation activities including creating, formatting, issuing, filing and tracking of department documentation for AS&T, and ensure departmental document compliance.
  • Maintain the electronic AS&T Records Management System (RMS) to send archived records offsite to Iron Mountain.
  • Assist with the maintenance and alignment of the biologics analytical documentation and change control SOP's and workflows, ensuring alignment with directive and governance structures.
  • Monitor and support change control process and change action follow-ups to ensure timelines are met for regulatory submissions and/or manufacturing deliverables.
  • Perform detailed review of change controls (including method mark-ups) for accuracy, robustness, and completeness.
  • Present/discuss pending and/or delayed change actions at monthly sub-team meetings for each commercial program.
  • Identify causes of documentation and change control process rework/delay, and implement actions to streamline process.
  • Support activities in the Global Testing Standards system.


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

  • Must have experience with GMP regulations and have demonstrated ability to follow written standard operating procedures (SOPs), as well as experience with Microsoft Word, Powerpoint, Excel, TrackWise and/or similar IT solutions.
  • The ideal candidate will have industry experience with documentation systems and change control for commercial biologics, as well as familiarity with analytical method format and validation/transfer documentation.
  • Must demonstrate skills in teamwork, project planning, strong organizational skills, computer competency, and effective written and verbal communications.
  • To be successful in this role, the candidate must embrace collaboration with partners, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture.