Drug Device Combination CMC support
50 Northern Ave, Boston, MA 02210 Boston, MA 02210 US
General Position Summary:
Provides Combination Device CMC support for Quality Assurance processes as defined under Key Responsibilities below.
The responsibilities of this position may include, but are not limited to, the following:
· Assists in CMC QA activities to support clinical development, submission, and approval of drug-device combination product.
· Support device design control activities and documentation reviews
· Preparation of Device History File.
· Preparation of Human Factor Risk Analysis
· Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
· Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
· Assist with generation of Metrics and Metrics reports
· Performs Data Entry into GxP Regulated Systems as required
· Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
· Coordinates document approval, as necessary
· Schedules and coordinates meetings for CMC Quality Operational team (Leadership meetings, Extend group meetings). Manages agenda and minutes and follows up on all action items
· Bachelor’s degree and 0 – 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background.
· Good Understanding of regulations, guidelines, procedures, and policies relating to development, registration and manufacturing of drug-device to expedite the submission, review and approval of global CMC applications.
· Strong written and verbal communication skills
· Attention to detail
· Organizational/planning and coordination skills
Target pay: 70-80/hr
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