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Drug Device Combination CMC support

Boston, MA 02210

Posted: 05/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 563321 Is job remote?: No Country: United States

Job Description

General Position Summary:

Provides Combination Device CMC support for Quality Assurance processes as defined under Key Responsibilities below.

Key Responsibilities:

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


Minimum Qualifications:

· 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.


Preferred Qualifications:

· Adaptability/flexibility

· Strong written and verbal communication skills

· Attention to detail

· Organizational/planning and coordination skills

Target pay: 70-80/hr
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