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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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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