Sr. Quality Assurance Specialist

About Akoya Biosciences:
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and treatment response. Akoya offers the PhenoCycler® and PhenoImager® platforms to serve the diverse needs of researchers across discovery, translational and clinical research.

Position Summary/Impact:

Akoya Biosciences is looking for a dynamic and energetic person to fill the role of Senior Quality Assurance Specialist based at our Marlborough, MA location. As an integral member of our Quality team, you will be responsible for successful management and execution of Non-Conformance/Corrective and Preventive Action (NC/CAPA) activities across the Quality Management System (QMS).

In this role you will collaborate with our top-talent in cross functional teams supporting the development, manufacture, distribution, and support of our products by active oversight and process management of the NC/CAPA system. You will act as the system/process expert, coordinating and driving execution of all activities to advance actions, build accountability, gain efficiency, and maintain compliance. This role will interact with all areas of our business to lead enhancement of our processes while innovating and driving actions to generate engagement and continuous improvement of the organization & QMS.

To be successful in this role you must be an excellent communicator, quick learner, and be adaptable while remaining task focused to meet the demands of a fast-paced and rapidly growing organization.

Duties & Responsibilities:

• Manage and coordinate the day-to-day activities within the NC/CAPA system in alignment with internal policy and procedures.
• Oversight and management of all NC/CAPA records within the eQMS tool (Arena).
• Facilitate product and process NC/CAPA investigations from issue identification through implementation of solution and effectiveness monitoring by working with key stakeholders and functional SMEs.
• Responsible for performing timely, detailed CAPA engineering tasks including assessing issue descriptions, reviewing data sources, assisting with root cause analysis and quality problem solving.
• Project manage all aspects of NC/CAPA activity which includes gaining the commitment of cross functional resources, scheduling team meetings, and ensuring deliverables per project timelines.
• Function as the Process Owner & NC/CAPA expert in the system supporting employees across the organization.
• Collaborate with cross-functional teams & technical SME for accuracy, completeness, and compliance of all actions & related documentation.
• Lead, coach, and mentor cross functional teams to gain proficiency with the system tools and implementation of appropriate root cause analysis techniques.
• Facilitate and report progress on improvement actions including generation of metrics for QMS monitoring.
• Develop and deliver various trainings for NC/CAPA and other problem-solving methodologies.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Work effectively with all levels of management to ensure action plans can be supported and that costs/resources needed to implement the plan are available.
• Establish & maintain a Quality Review Board (QRB) and CAPA Review Board (CRB) meeting with site management and leadership teams.
• Drive continuous improvements of the process you are involved in to increase efficiency and engagement within the organization.
• Manage governing quality system procedures related to your process through monitoring and updates, as necessary.
• Manage/lead quality projects/initiatives that help Akoya achieve our strategic vision and key initiatives.
• As process owner, present NC/CAPAs during audits and other internal reviews such as Management Review
• Perform other tasks/activities as assigned.
• Act as a change agent approaching challenges with inherent curiosity, an open mind, and collaborate towards positive outcomes.
• Exemplify Akoya values on the job by focusing actions on Leadership, Customer First, Innovation, Efficiency, and Graciousness
• Other duties as assigned.

Qualifications/Skills:

• Bachelor’s degree in a related technical field and 5+ years of relevant experience OR the equivalent combination of education, experience and/or training.
• Experience working within a compliant QMS (ISO 9001, ISO 13485, or equivalent) in regulated industry (Medical Device, Pharmaceutical, etc.) supporting a manufacturing/production site.
• Relevant application, fileshare, and organizational collaboration tools experience (i.e. MS Office 365, MS SharePoint, MS Teams, Adobe Creative Cloud, etc.).
• Prior experience with web/cloud-based PLM/eQMS platforms, Arena PLM preferred.
• Demonstrated attention to detail and accuracy.
• Adept at communicating effectively up, down, and across, inside & out of the organization.
• Awareness and familiarity with ERP & PLM system architecture and manufacturing documentation (e.g., item/part, BOM, MPN, etc.) with regular usage in prior roles.
• Effective organizational and time management and the ability to work towards multiple priorities while delivering quality outcomes.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

The hiring range for this position is $80,000 to $113,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!

Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.