Quality Assurance Associate II

2 weeks ago

Framingham, United States Pyramid Consulting Full time

Immediate need for a talented Quality Assurance Associate II. This is a 12+months contract opportunity with long-term potential and is located in Framingham, MA (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-50129

Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

  • 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 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

Key Requirements and Technology Experience:
  • Key skills; Batch records, Quality Assurance, Deviation
  • Manager Intakes : 3-6 years of experience, but open to someone with less experience.
  • A minimum of 2 years in the Pharmaceutical Industry with at least 1 in a quality environment.
  • Open to candidates willing to relocate at their own expense
  • M.S./MBA plus 2 years' experience in a pharmaceutical or GMP environment with at least 1 year in a Quality related field.
  • Minimum B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years in a Quality related field;
  • Degree preferably in Science field - possibility for OT, but not required
  • Attention to detail is critical, communication, organizational skills
  • Top 3 nice to have - PM, knowledge of EU and FDA guidances, experience in a Quality role, experience in a GMP environment, aseptic processing experience.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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