QA Associate

KPS Life is seeking a QA Associate to work on-site (hybrid) at one of our Sponsor partners in Boston, MA.

Quality Assurance (QA) Associate / Sr. Associate

The successful candidate will work to ensure internal compliance with 21 CFR Parts 11, 210, and 211 while supporting Sponsor oversight and collaborations with qualified third-party vendors and contract service providers (e.g., CMO’s, CRO’s) operating in the highly regulated GCP/GMP/GLP life sciences space. This position will play a critical role in enhancing and streamlining document systems and workflows while also contributing to the continued development and enhancement of robust Quality Management Systems.

Essential Duties And Responsibilities

• Administers the EDMS and overall Document Control function for supporting quality operations, ensuring compliant document generation, distribution, periodic review, and version control.
• Tracks and monitors open departures (deviations, CAPA, change control, product complaints) within the EDMS. Assists the clinical and CMC development teams with departure initiation and workflows.
• Administers and oversees employee training requirements and generates training compliance metrics. Works with cross-functional department Leads to ensure appropriate training curricula are assigned.
• Supports supplier qualification and audit lifecycle management activities. Maintains the Qualified Vendor List.
• Develops and optimizes workflows, trackers, dashboards, and user guides to support QA operations and inter/intra-department communication.
• Supports SOP review, approval, distribution and training functions. Tracks and ensures the execution of periodic reviews. Ensures consistency in SOP format, metadata, and document references.
• Reviews and approves batch records for packaging and labeling of drug product.
• Administers new employee Quality Assurance orientation and onboarding.
• Archives vendor GXP documentation within controlled access SharePoint.

Education And Qualifications

• 5+ years' experience administering quality management systems or in related roles such as CMC operations, GMP-compliant manufacturing, or pharmaceutical project management.
• A four-year degree is preferred; however, a two-year technical degree may be acceptable with an appropriate level of experience.
• Experience administering or operating within Electronic Document Management software is required (e.g., ZenQMS, Veeva, etc.).
• Experience designing operational systems, workflows, and trackers using productivity and project management tools is highly desirable.
• Proficiency with MS Office software.
• Self-starter attitude with a proactive, results-oriented focus and willingness to assume additional responsibilities as needed.
• Strong time management skills to successfully complete a variety of job duties and responsibilities in a timely manner.
• Must be able to engage with a variety of people with different technical levels and educational backgrounds.
• Willing to work onsite 2 days per week with the ability to work from home when not in the office.

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