Quality Assurance Associate in Framingham, MA

  • Title: Quality Assurance Associate
  • Code: RCI-9324
  • RequirementID: 123187
  • Location: Framingham, MA 01701
  • Posted Date: 12/05/2024
  • Duration: 12 Months
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  Job Description

8:00 am - 4:30 pm EST; Mon-Fri

Hybrid role Free Parking at this site
Local Candidates only Possible Over time, stated some candidates appeared overqualified.


Seeking Mid level experience.

Must Have:

  • 3+ in Pharma or GMP M.S./MBA at least 1 year in a Quality related field
  • B.S. Degree at least 2 years in a Quality related field

  Top Must Haves

  • Attention to detail is critical, communication, organizational skills

 Top 3 nice to have/ Preferred Skills

  • Project Management,
  • Knowledge of EU and FDA guidance’s,
  • Experience in a Quality role,
  • Experience in a GMP environment,
  • Aseptic processing experience.

 Duties

  • Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and/or approval.
  • Maintain organization of project deliverables for external partner project using applicable tools.
  • Identify and communicate quality risks in a pro-active and collaborative manner maintaining the business interests of Client and consideration of suitable outcome for the projects.
  • Participate in and support batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
  • Develop trusting team partnerships to ensure highly collaborative project outcomes.
  • Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).

 

 

 



About Rangam:

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