Quality Assurance Associate II Clinical

** Adecco Healthcare & Life Sciences*
* ** Quality Assurance Associate II - Genomic Medicine Unit (GMP / CMO Oversight)*
* ** Hybrid (3 Days Onsite - Framingham, MA) | Temp Role | Possible Extension*
* ** Pay** : 40-46.5/hr Depending on education and experience level

** Position Summary*
* The Quality Assurance Associate II supports GMP quality oversight for external manufacturing and testing partners within the Genomic Medicine Unit. This role focuses on ensuring compliance with regulatory expectations across GMP documentation, batch record review, deviations, CAPAs, and change controls for Sanofi-sponsored genomic medicine programs.

The position works closely with internal R&D and Quality teams as well as external Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) to ensure quality excellence, regulatory compliance, and consistent execution of CMC requirements.

** Key Responsibilities*
* ** GMP Quality Oversight & Documentation Review*
* + Review GMP documentation including batch records, analytical data, specifications, validation protocols, and reports

+ Ensure documentation aligns with quality and regulatory standards prior to approval or release

+ Support organization and tracking of project deliverables using quality systems and tools

+ Maintain documentation accuracy and ensure compliance with SOPs and regulatory expectations

** Deviation, CAPA & Change Control Management*
* + Participate in and/or lead deviation investigations, risk assessments, and change control processes

+ Support CAPA development and implementation in accordance with GMP requirements

+ Identify, communicate, and mitigate quality risks proactively

+ Ensure timely resolution of quality issues impacting manufacturing or testing activities

** External Partner & CMO Quality Oversight*
* + Act as a quality liaison for external manufacturing and laboratory partners

+ Support development and review of Quality Technical Agreements

+ Ensure CMOs/CLOs adhere to established quality standards and regulatory expectations

+ Participate in external partner assessments and audits as needed

** Cross-Functional Collaboration & Quality Culture*
* + Serve as Quality focal point within assigned CMC Quality sub-teams

+ Collaborate with Development, Manufacturing, Regulatory, Engineering, and external partners

+ Promote a strong quality culture and continuous improvement mindset

+ Support site and project implementation activities as assigned

** Required Qualifications*
* + Bachelor's degree with 4+ years of experience in pharmaceutical or GMP environment, including at least 2 years in a Quality-related role

OR Master's/PhD with 2+ years of Quality experience

+ Strong experience in GMP pharmaceutical or biotech environments

+ Hands-on experience with CAPA, deviations, and change control systems

+ Familiarity with Quality Management Systems and documentation tools

+ Proficiency in Microsoft Office Suite

+ Experience working in regulated environments (GMP, ICH, FDA, EMA)

+ Strong attention to detail and ability to manage multiple priorities

+ Excellent communication and teamwork skills

** Preferred Qualifications*
* +

Experience with Gene Therapy or ATMP (Advanced Therapy Medicinal Products) processes

+

Experience with aseptic processing environments

+

Experience with Veeva and/or SAP systems

+

Experience with external partner or CMO quality management

+ Exposure to CMC (Chemistry, Manufacturing & Controls) requirements

** Core Competencies*
* + Strong quality mindset and regulatory awareness

+ Ability to manage complex documentation and compliance workflows

+ Strong interpersonal and stakeholder management skills

+ Ability to work independently with minimal supervision

+ Strong organizational and project management capabilities

+ Ability to influence cross-functional and external partners

+ High attention to detail and problem-solving ability

+ Commitment to continuous improvement and quality excellence

** Work Environment*
* + Hybrid role: 3 days onsite in Framingham, MA

+ Free onsite parking

+ No exposure to extreme heat, cold, or hazardous chemicals

+ Standard business hours:
Monday-Friday, 9:00 AM - 5:00 PM EST

+ Temp assignment with possible extension

+ Role involves meetings, documentation review, deviations management, and cross-functional collaboration

** Why work for Adecco?*
* + Weekly Pay

+ 401(k) Plan

+ Skills Training

+ Excellent medical, dental, and vision benefits

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

IMPORTANT:
This role is being recruited for by Adecco's Healthcare & Life Sciences division, not your local Adecco Branch Office.

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