Quality Assurance Associate II

Adecco US, Inc. Quality Assurance Associate II Framingham, MA Apply Adecco Medical & Science is hiring a Quality Assurance Associate II for our Pharmaceutical partner in Framingham, MA The anticipated hourly wage for this position is between $45 and $46.59 Hourly wage may depend upon experience, education, geographic location, and other factors. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, 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. The R D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of 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 the company 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 c

GMP/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 project Soft skills: 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 Agreement Education:

B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field

Pay Details:

$45.00 to $46.59 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Active Filters Quality Assurance Associate II Framingham, MA Clear All Apply