Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Sr. Director Of Cmc
Recruited by EPM Scientific 8 months ago Address Greater Boston, United States
Associate Director Of Drug Product Cmc
Recruited by EPM Scientific 8 months ago Address Greater Boston, United States
Mig Welder Jobs
Recruited by SURESTAFF 8 months ago Address , Terrell, 75160 $22 - $25 an hour
Welder Jobs
Recruited by Ferguson Fire & Fabrication Inc 8 months ago Address , Chicopee, 01022 $18.28 - $27.42 an hour
Welder Jobs
Recruited by Weir Group 9 months ago Address , Newton
Welder - Repcon Jobs
Recruited by Emcor 9 months ago Address , Houston
Senior Welder Jobs
Recruited by San Antonio Water System 9 months ago Address , San Antonio $60,873 - $104,445 a year
Welder Jobs
Recruited by CSE Inc 9 months ago Address , Troy, 22974
Welder Helper Jobs
Recruited by Canyon Pipeline Construction, Inc. (S4) 9 months ago Address , Centerville, 84014
Welder Jobs
Recruited by Martin Sprocket and Gear, Inc. 9 months ago Address , Burleson, 76028, Tx
Welder Ii Jobs
Recruited by Plug Power Inc 9 months ago Address , Houston, 77075, Tx
Welder Combination Jobs
Recruited by Zachry Group 9 months ago Address Sabine Pass, TX, United States
Body Tech / Collision Tech
Recruited by Crash Champions 10 months ago Address Austin, TX, United States
Welder Jobs
Recruited by XL Pro Staffing and Consulting Group 10 months ago Address Garland, TX, United States
Associate Director Global Regulatory Cmc - Cell Therapy
Recruited by Shepherd Regulatory Search 10 months ago Address Greater Boston, United States
Contract Coordinator-Recent Graduates Jobs
Recruited by Primary Services 10 months ago Address Houston, TX, United States
Mig Welder - Manufacturing (Ft)
Recruited by Texas Staffing Solutions, LLC 10 months ago Address San Antonio, TX, United States
Combination Building Inspector Jobs
Recruited by CITY OF GALVESTON 11 months ago Address Galveston, TX, United States
Welder Jobs
Recruited by Schuff Steel Co 11 months ago Address , Humble, 77396, Tx
Welder Jobs
Recruited by Renewable Energy Systems Limited 11 months ago Address , Abernathy, 79311, Tx $19 - $30 an hour
Welder Jobs
Recruited by City of Harlingen, TX 11 months ago Address , Harlingen, Tx
Mig Welder Jobs
Recruited by Cornerstone Building Brands 11 months ago Address , Lexington, 38351, Tn $20 - $21 an hour
Combination Building Inspector* Jobs
Recruited by City of Henderson, NV 11 months ago Address , Henderson, Nv $40.59 - $46.48 an hour
Welder Jobs
Recruited by STEWART WELDING & MACHINE, INC. 11 months ago Address Andrews, TX, United States
Infrastructure Engineer - Mobile Device Management
Recruited by Gundersen Health System 11 months ago Address , Onalaska, 54650, Wi
Associate Welder Jobs
Recruited by Simpson Strong-Tie 11 months ago Address , Mckinney, 75069, Tx $19 an hour
Certified Welder Jobs
Recruited by Napco Precast Llc 11 months ago Address , San Antonio, 78250, Tx $20 an hour
Welder Jobs
Recruited by Lippert 11 months ago Address Waxahachie, TX, United States
Welder Foreman Jobs
Recruited by Harris County 11 months ago Address , Baytown, Tx $77,521 a year
Welder Jobs
Recruited by Lippert 11 months ago Address Shiner, TX, United States
Welder Jobs
Recruited by NOV Inc. 11 months ago Address , Victoria, 77905, Tx
Welder Jobs
Recruited by Hi-Vac Corporation 11 months ago Address , Marietta, 45750, Oh $18 - $24 an hour
Multimodality Tech Jobs
Recruited by Baylor Scott & White Health 11 months ago Address , Round Rock, 78665, Tx
Welder Jobs
Recruited by Big Tex Trailer Manufacturing Llc 11 months ago Address , Wills Point, 75169, Tx From $17.50 an hour
Welder Jobs
Recruited by Imperial Group Manufacturing 11 months ago Address , Dublin, 24084, Va $18.00 - $18.75 an hour
Contract Support Specialist Jobs
Recruited by Brock Solutions 11 months ago Address , Dallas, Tx
X-Ray Tech Jobs
Recruited by Vitana Inc 11 months ago Address , Odessa, Tx From $54.60 an hour
Echocardiogram Tech Jobs
Recruited by Christus Health 11 months ago Address , Tyler, 75701, Tx
Welder Jobs
Recruited by Southwest Shipyard Lp 11 months ago Address , Houston, 77012, Tx
Water Coordinator - Contract
Recruited by ConocoPhillips 11 months ago Address , Midland, Tx
Entry Level Mobile Device And Network Engineer / Plano, Tx / Mobile / Sags
Recruited by BTI Solutions 11 months ago Address , Plano, Tx
Anesthesia Tech Jobs
Recruited by New England Baptist Hospital 11 months ago Address , Boston, 02120, Ma
Drug Device Combination Cmc Support, Quality Assurance (Contract)
Recruited by Vertex Pharmaceuticals 1 year ago Address , Boston, 02110, Ma

Drug Device Combination Cmc Support (Contract)

Company

Vertex Pharmaceuticals
Address , Boston, 02210, Ma
Employment type FULL_TIME
Salary $70 - $80 an hour
Expires 2023-07-27
Posted at 11 months ago
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:
  • Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
  • Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
  • 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
  • Support device design control activities and documentation reviews
  • Assist with generation of Metrics and Metrics reports
  • Preparation of Human Factor Risk Analysis
  • 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
  • Preparation of Device History File.
  • Assists in CMC QA activities to support clinical development, submission, and approval of drug-device combination product.
  • Coordinates document approval, as necessary

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:
  • Attention to detail
  • Organizational/planning and coordination skills
  • Adaptability/flexibility
  • Strong written and verbal communication skills
Pay Range:
$70-$80/hr
Requisition Disclaimer:
This job posting is for a is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals. The individual selected for this role will be offered the role as an employee of a third-party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Terms and Conditions. Agreeing to these terms, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employees to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored in our database. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact us at [email protected].

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors