QA Operations Specialist

Neurotech Pharmaceuticals, Inc.; Cumberland (RI); On-site; USD 110,000 - 140,000; Full time

Job summary

Neurotech Pharmaceuticals, Inc., now part of Alconis, operates at Cumberland, RI, focusing on Encapsulated Cell Therapy for chronic eye diseases. The QA Operations Specialist, Validation, provides QA oversight of qualification and validation activities for equipment, facilities, utilities, systems, and processes, ensuring CGMP and GDP compliance.

You will collaborate with Validation, Manufacturing, QC, and other teams; mentor personnel on documentation; support change controls, deviations, and

Qualifications

• Bachelor’s degree in Science, Engineering, or related field with 5–7 years in QA/validation in GMP-regulated environment.
• Solid background in QA/Systems and/or Validation including regulations, guidelines, and compliance issues.
• Experience with quality review of qualification and validation documents.

Responsibilities

• Perform independent QA review and approval of qualification and validation documentation, including protocols, reports, discrepancies, requirements specifications, risk assessments, and supporting records.
• Ensure validation documentation complies with CGMP and GDP and is aligned with approved procedures.
• Provide QA oversight of qualification and validation lifecycle activities, including IQ/OQ/PQ, and assess changes or discrepancies that may impact the validated state.
• Collaborate with Validation, Mfg, QC, and other functions to support validation activities.
• Provide technical mentorship on qualification and validation documentation to Neurotech personnel.
• Support change controls by performing impact assessments for QA relevant to systems/equipment/facilities/utilities/processes changes.
• Ensure deviations are raised appropriately and support investigations related to systems/equipment/facilities/utilities/processes.
• Participate in Root Cause Analysis, CAPAs, and continuous improvement initiatives.
• Aid in identification of opportunities for process improvements.

Skills

Quality Assurance

Validation oversight

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in Science or Engineering

Tools

MS Office

Monday.com

Teams

Intellect

SAP

CMMS

MS Project

Job description

Neurotech Pharmaceuticals, Inc. now part of Alconis located in Cumberland, RI and Needham, MA. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech's first commercial product, ENCELTO TM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.

QA Operations Specialist, Validation is responsible for providing Quality Assurance oversight, review, and approval of qualification and validation activities associated with equipment, facilities, utilities, systems, and manufacturing processes at the Cumberland, RI site. The position serves as the primary QA partner to Validation, ensuring activities are performed in accordance with approved procedures, regulatory requirements, and GMP expectations. The role also supports quality investigations, change controls, and continuous improvement initiatives.

Job Requirements

• Perform independent QA review and approval of qualification and validation documentation, including protocols, reports, discrepancies, requirements specifications, risk assessments, and supporting records.
• Ensure validation documentation complies with NT's approved validation procedures and in accordance with CGMP and GDP.
• Provide QA oversight of qualification and validation lifecycle activities, including IQ/OQ/PQ, and assess changes or discrepancies that may impact the validated state.
• Collaborate with Validation, Mfg, QC, and other functional areas to support validation activities.
• Provide technical mentorship and guidance to Neurotech personnel on qualification and validation documentation, including corrections/notes, to contribute to Team development and understanding of these processes.
• Support change controls by performing impact assessments for QA Operations relevant to systems/equipment/facilities/utilities/processes types of changes.
• Ensure deviations are raised to the appropriate area owner and provide support as Quality Partner for investigations related to systems/equipment/facilities/utilities/processes.
• Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate and approve these quality system elements, as delegated by management.
• Participate and lead rapid response efforts, providing quality guidance for quality system improvements and investigations.
• Participate as the Quality Assurance representative in Root Cause Analysis activities to support deviation investigations of moderate to high complexity.
• Support OOS investigations and CAPAs, as required.
• Aid in identification of continuous improvement opportunities and participate in practical process improvement initiatives.

Education & Experience

• Bachelor's degree in Science, Engineering, or a related discipline with 5-7 years of relevant experience in Quality Assurance, preferably involving qualification and validation oversight within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• May substitute proven experience for education requirement.
• Solid background in Quality Assurance/Systems and/or Validation including regulations, guidelines, and identification of compliance issues.
• Experience with quality review of qualification and validation documents.

Knowledge, Skills & Abilities

• Ability to compromise and understand multiple points of view to solve complicated quality situations.
• Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
• Knowledge in QMS management and support (Deviation, CAPA, and Change Control), as well as significant GDP proficiency.
• Ability to manage multiple tasks and expectations and deliver timely requirements in a deadline-oriented environment.
• Excellent communication skills, both verbal and written.
• Keen attention to detail.
• Ability to identify risks early and assist with proactive mitigation plans.
• Ability to work both independently with direction and within project teams to attain goals as well as being self-motivated and showing initiative.
• Proficiency in using multiple electronic software applications required to perform duties (i.e., MS Office, Monday.com, Teams, Intellect, SAP, CMMS, MS Project).

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.