Quality Assurance Associate II

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.

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