Quality Assurance Associate II (Clinical)

Immediate need for a talented Quality Assurance Associate II (Clinical). This is a 06 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:26-11331

Pay Range: $30 - $43/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 GMP documentation and ensure alignment with quality and regulatory expectations prior to release and/or approval (batch records, analytical data/specifications, validation protocols/reports, deviations, change controls, CAPAs, etc.).
• Maintain organization of project deliverables for external partner project using applicable tools.
• Identify, communicate, and mitigate quality risks in a pro-active and collaborative manner maintaining the business interests of consideration of suitable outcome for the projects.
• Participate in and support, or lead where appropriate, batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
• Develop trusting internal team partnerships to ensure highly collaborative project outcomes.
• Develop trusting partnerships with external partners to ensure they understand, respect, and implement guidance on all Quality matters.
• Contribute to and review in the development of Quality Technical Agreements.
• Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).
• Promote Quality excellence and Quality Culture as a Quality Culture Liaison.
• Lead and/or support the drive for consistency and continuous improvement.
• Make decisions that uphold ethical standards.
• Support site project implementations, as assigned.

Key Requirements and Technology Experience:

• Skills-Experience in the pharmaceutical industry with a quality focus, including external partner/ CMO management
• Knowledge of Quality Systems and Quality Management programs
• Understanding of cGMP/ICH/FDA/EMA regulations, with background in regulations and guidance for drug substance/ drug product manufacturing and/or gene therapies
• Familiarity with Chemistry Manufacturing Controls (CMC) requirements
• Experience managing quality operations for manufacturing projects
• Outstanding interpersonal and communication skills, including presentation abilities
• Being a demonstrated team player with experience contributing to multi-disciplinary project teams
• Working effectively with minimal supervision while maintaining strong collaborative relationships
• Strong project management skills and ability to work well under pressure
• Being highly organized with excellent attention to detail
• Managing multiple priorities while maintaining high productivity
• Having the ability to influence across internal and external networks, including Development, Manufacturing, Engineering, Digital, Quality, Regulatory Affairs, and external partners
• Research & Development activities and processes (specifically in a CMC related field)
• Experience with Gene Therapy/ ATMP processes (preferred)
• Experience with aseptic processing (preferred)
• Proficiency with quality management systems and documentation tools
• Experience with external partner audits and quality assessments
• Knowledge of Quality Technical Agreements
• B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field
• English: Fluent professional practice
• Manager Notes - Open to candidates willing to relocate at their own expense
• Free parking onsite
• No extreme and heat and cold; No heavy lifting or exposure to chemicals 
• Day to day: Walk throughs, document review, deviations managements, meetings, interfacing with internal customers. 
• Must have skills/ Required: -B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field or MS/ PHD with 2 years of related experience in Quality role. 
• GMP, pharma/ biotech exp required
• Capa’s, deviations 
• MS Office Suite 
• Veeva, SAP 
• Team player, attention to detail
• Self-starter 
• Experience with Gene Therapy/ ATMP processes (preferred)
• Experience with aseptic processing (preferred)/ understanding

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, color, 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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