QA Operations Specialist II at Neurotech Pharmaceuticals

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform, Encapsulated Cell Technology (ECT), designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, by leveraging ECT's innovative approach providing sustained, targeted treatment directly to the eye.

The Quality Operations Specialist II is responsible for supporting lot disposition activities and driving release activities for operations including raw materials for manufacturing, packaging, inspection, and associated non batch specific activities for the Cumberland, RI site. Additionally, the role leads and provides guidance/expertise for implementation of practical process improvements, continuous improvement initiatives and quality investigations.

Please note, this role is not eligible for agency recruiting support. Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Job Requirements

• Perform quality batch record and documentation review to allow release of raw materials and finished products.
• Perform regular quality assessments of facility, personnel and documentation of both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as the need arises by site procedures and CGMPs.
• Critically review various types of QMS documentation to ensure completeness, accuracy and compliance including but not limited to product complaints, annual product reviews, Supplier Notifications, SOPs, master plans, Deviation investigations, CAPAs and Change Controls.
• Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate and approve these quality system elements, as delegated by management.
• Daily interaction with Neurotech personnel to assist with troubleshooting, documentation corrections/notes, and guidance.
• Develop and drive Neurotech’s quality culture and environment by aiding personnel in understanding the application of policies and controls.
• Participate and lead rapid response efforts, providing quality guidance for quality system improvements and investigations.
• Ensure deviations are raised to the appropriate area owner and provide support as Quality Partner for these investigations.
• Process NCMRs (Nonconformance Material Reports) for nonconforming materials and finished products.
• Perform quality review and approval of environmental monitoring records, facilities records (i.e., calibration/preventative maintenance, pest control, cleaning logs, etc.), and EH&S records.
• Participate as the Quality Assurance representative in Root Cause Analysis activities to support deviation investigations of moderate to high complexity.
• Support OOS investigations as required.
• Support review and approval of validation protocols, reports, and records.
• Aid in identification of continuous improvement opportunities and participate in practical process improvement initiatives.

Education & Experience

• Bachelor of Science or Engineering and 7-10 years relevant work experience within QA and in the cGMP Biotechnology and/or Medical Device industry.
• May substitute proven experience for education requirement.
• Solid background in Quality Assurance/Systems including interpreting regulations, guidelines, and identification of compliance issues.

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, as well as significant GDP proficiency.
• Ability to manage multiple tasks and expectations and deliver timely requirements.
• Experience in drafting audit reports and developing gap assessments and investigations.
• Excellent communication skills, both verbal and written.
• Ability to work both independently with direction and within project teams to attain goals.
• Proficiency in using multiple electronic software applications required to perform duties (i.e., MS Office, Monday.com, TrackWise, Intellect, SAP, Blue Mountain).

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.