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Job Requirements of Quality Assurance Associate II:
-
Employment Type:
Contractor
-
Location:
Framingham, MA (Onsite)
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Quality Assurance Associate II
Careers Integrated Resources Inc
Framingham, MA (Onsite)
Contractor
Title: Quality Assurance Associate II
Location: Framingham, MA (HYBRID)
Duration: 9 Months+ Possible Extension
Pay Range: $42-$46/hr
Manager Notes:
Our Team:
Location: Framingham, MA (HYBRID)
Duration: 9 Months+ Possible Extension
Pay Range: $42-$46/hr
Manager Notes:
- Hybrid role 3 days onsite
- Day to day: Walk throughs, document review, deviations managements, meetings, interfacing with internal customers.
- 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, Deviations
- MS Office Suite
- Veeva, SAP
- Experience with Gene Therapy/ ATMP processes (preferred)
- Experience with aseptic processing (preferred)/ understanding
Our Team:
- The R&D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of Client-sponsored GMP manufacturing and testing of genomic medicines at third parties.
- This position will join a collaborative team dedicated to ensuring phase-appropriate manufacturing excellence while maintaining strong partnerships with Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs).
- 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 Client and 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 Clients 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.
- 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
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