Bristol Myers Squibb Analytical Change Control and Documentation Specialist in Devens, Massachusetts
The primary role is to coordinate and support analytical change control and documentation activities for biologic products, ensuring compliance with cGMP requirements as part of the Analytical Science and Testing (AS&T) team, while partnering with GTS on the currency of our testing methods and standards.
Coordinate compilation, formatting, and approval of biologics clinical and commercial specifications.
Monitor and drive change controls to approval and closure by tracking action items, impact assessments, regulatory and quality approvals, and implementation activities (change actions) ensuring timelines are met to support 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 product.
Coordinate documentation activities including creating, formatting, issuing, filing and tracking of department documentation for AS&T, and ensure departmental document compliance.
Maintain the electronic AST 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.
Identify causes of documentation and change control process rework/delay, and implement actions to streamline process.
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 Word, Powerpoint, Excel, TrackWise and/or similar IT solutions.
The ideal candidate will have industry experience with documentation systems and commercial change control for 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.
A Bachelors, Associates, or High School degree/diploma in a systems environment, document management, technical writing or related disciplines with at least 2, 5, or 15 years of industrial technical document experience in relevant fields, respectively.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled