Job Title: QA Specialist - Partner Change Control Coordinator
This is a temporary contract position for a 6-month term. The contract QA specialist/Sr. Specialist Partner Change Coordinator will perform day-to-day activities related to management of partner impacting change controls within the L-Seagen Veeva Quality management system.
Principal Responsibilities:
* Participate in internal and joint change planning activities to understand change types, change strategies and represent PC1 in determining change reporting requirements with partners.
* Initiate and update status of change planning and change control communications with partners in Pfizer communications tracking tools throughout change control process.
* Review and advise on partner impacting change controls entered in the Veeva QMS providing feedback to change owners on specific partner requirements.
* Manage partner impacting changes through the change control process depending on partner change requirement such as prior approval required, post approval required, and notification only.
* Communicate with partner representatives and internal stakeholders ensuring change control process progresses per specified timelines and due dates. Assist with issue management through the process ensuring both partner and Pfizer objectives are met.
* Ensure all required partner documentation is received and included in Pfizer Veeva change controls prior to progressing change records to QA approvals and closure.
* Participate in continual improvement, if necessary, under the oversight of PC1 leadership.
* Collect and assist with reporting on relevant metrics.
* Contribute to milestones related to specific projects as necessary under PC1 Leadership.
Required Qualifications:
* 2+ years in GMP change control operations, in the biopharmaceutical or the pharmaceutical industry.
* Hand-on experience with Veeva QMS and TrackWise change control applications in the GMP setting.
* Working knowledge of cGMP, specifically GMP change control.
* Strong written and oral communication skills.
* Ability to manage day-to-day workload with minimal oversight.
* Proven ability to work effectively in a fast-paced team environment.
* Proven ability to persevere and persuade in negotiations.
* Highly organized and detail oriented.
* Strong team player that can also work independently to achieve objectives.
Preferred Qualifications:
* Prior QA experience.
Education:
* Bachelor's degree in a relevant field or equivalent experience.