Senior Quality Specialist, Quality Operations

Full Time
Durham, NC
Posted Today
Job description

StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.

We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.

Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators, we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio's offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC

Ideal Candidate

We are seeking a flexible Senior Quality Specialist, with a breadth of Quality Operation experience. Responsibilities and experience may include the following; partnering with Manufacturing providing Quality training and oversight as well as supporting; batch record generation, document systems, change management, deviations, CAPA and support for product/raw material disposition. Ability to understand and implement priorities and workload and to establish strong collaborative relationships with peers.

The Senior Quality Specialist, Quality Operations, utilizes StrideBio's quality system in compliance with current good manufacturing practice regulations and company policies and procedures. Supports workflows to assure timely supply of product. Supports production floor activities including room release as well as the evaluation and disposition of labeling, raw materials, intermediates, and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.

*Local NC Candidates Only*


Responsibilities

  • Utilizes quality assurance system in compliance with current good manufacturing practice regulations.
  • Supports the evaluation and disposition of labeling, raw materials, intermediates, and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
  • Supports identification of root causes, recommends, and implements corrective actions to prevent recurrence.
  • Employs metrics to track the performance of operations and quality systems
  • Assist in the training activities of personnel.
  • Ability to understand risk assessments which results in an overall improvement in consistency and risk awareness.
  • Responsible for supporting continuous improvement initiatives as well as interfacing with other functional areas including manufacturing, facilities, QC, and other Quality departments projects/activities.
  • Understands regulatory requirements and implements Quality procedures.
  • Reviews and approves documents and records such as SOPs, deviations, change control requests, corrective and preventive action plans to ensure fulfillment of quality and compliance related requirements.
  • Supports internal audits of manufacturing, analytical testing, labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program.
  • Manages workflows to assure timely supply of product.
  • Performs other duties as assigned.

Requirements

  • Bachelor's degree in Science or relevant field or equivalent experience.
  • 3-5 years' applicable experience
  • Experience in working in Quality supporting a pharmaceutical manufacturing facility.
  • Working knowledge of industry guideline including cGMP, equipment qualifications, regulatory guidelines (i.e.: FDA, EU, ICH, ISO)
  • Experience in quality of aseptic processes Grade A through Grade D production areas and knowledge of appropriate technology
  • Excellent written/verbal communications
  • MS Office (Word, Microsoft Excel, and Power Point) required.

Preferred Qualifications

  • Working knowledge of cGXP, ICH, FDA, ISO, etc.
  • Creativity & Flexibility
  • Functional/Technical Skills
  • Problem Solving
  • Dealing with Ambiguity
  • Learning on the Fly
  • Informing
  • Listening
  • Drive for Results
  • Organizational Agility

What We Offer:

  • A competitive salary
  • A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology.
  • Exceptional opportunities for learning and growth
  • Company-paid holidays
  • Paid time off
  • Health, dental and vision care
  • Disability
  • Life insurance
  • 401(k) plan + match
  • Paid parental leave
  • Employee Assistance Program
  • On-site gym membership

Please visit www.stridebio.com to learn more.

COVID-I9 Vaccine Requirement: StrideBio requires all staff to be fully vaccinated for COVID-19 as a condition of employment. In accordance with applicable law, StrideBio will provide reasonable accommodations to employees who can provide a medical or religious exemption

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