US
0 suggestions are available, use up and down arrow to navigate them
PROCESSING APPLICATION
Hold tight! We’re comparing your resume to the job requirements…
ARE YOU SURE YOU WANT TO APPLY TO THIS JOB?
Based on your Resume, it doesn't look like you meet the requirements from the employer. You can still apply if you think you’re a fit.
Job Requirements of Quality Systems and Compliance Contractor:
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
Do you meet the requirements for this job?
Quality Systems and Compliance Contractor
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Management in product complaint handling including but not limited to: Intake of Product Complaints from the secured access mailbox Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & Pharmacovigilance Assist in providing product complaint metrics reports Develop training on product complaint handling Assist with revision of product complaint SOPs/WI Archive product complaints in accordance with policies
Act as a QS&C document control back-up support
Will support regulatory inspection preparation and onsite during inspections as required.
This position will be a hybrid role including both remote and onsite days
Skills:
1. Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.
2. Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.
3. Experience with Veeva Quality Docs and Veeva eQMS a plus
Education:
B.S. degree in life sciences, chemistry or engineering or equivalent and a minimum of 5 years experience in Pharmaceutical Quality or Regulatory
Act as a QS&C document control back-up support
Will support regulatory inspection preparation and onsite during inspections as required.
This position will be a hybrid role including both remote and onsite days
Skills:
1. Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.
2. Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.
3. Experience with Veeva Quality Docs and Veeva eQMS a plus
Education:
B.S. degree in life sciences, chemistry or engineering or equivalent and a minimum of 5 years experience in Pharmaceutical Quality or Regulatory
Get job alerts by email.
Sign up now!
Join Our Talent Network!