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Drug Device Combination CMC support - Boston - 18894

Boston, MA

Posted: 05/18/2023 Industry: Scientific and Life Sciences Job Number: 15644

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title:  Drug Device Combination CMC support
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
  • Duration: 6 months, potential to extend
  • Job Location:  Boston MA
  • Payrate: $60-80/hr
  • Job#: bh15644
Drug Device Combination CMC Support

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

 Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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