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Quality Assurance Associate II
Work Location:
Framingham, MA 01701 (Hybrid)
Assignment Duration:
8 months
HM Notes:
Open to candidates willing to relocate at their own expense
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.
Team player, attention to detail
Nice to Have:
Experience with Gene Therapy/ ATMP processes (preferred)
Experience with aseptic processing (preferred)/ understanding
Description The R&D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of 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).
Main 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 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 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
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
Technical skills
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
Education B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field
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Sprachkenntnisse
- English
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