Drug Device Combination CMC Support, Quality Assurance (Contract)
Full Time
Boston, MA 02110
Posted
Job description
Job Description
General Position Summary:
Provides temporary Combination Device CMC support for Quality Assurance processes as defined under Key Responsibilities below
.
The ideal candidate will have experience with design history file, FDA 21 CFR part 820 and ISO-13845. Experience in medical device and quality engineering is preferred.
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 3-5 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
This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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