Quality Specialist - United States
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- The Manufacturing Quality Specialist is responsible for support and administration of GMP activities within the Manufacturing department.
- This includes expertise in Trackwise for initiating, investigating, and writing Manufacturing Deviations, Quality Events, Corrective Actions / Preventive Actions (CAPAs), and Effectiveness Checks.
- In addition, the Manufacturing Quality Specialist is expected to lead efforts for Minor and Moderate scoped deviations, and participate in efforts for Major deviations. The MFG Quality Specialist is also responsible for coordinating minor-scoped Change Requests (CRs) for CAPA related procedural changes, coordination and organization of product change-over activities, and acting in support of the general GMP needs of the manufacturing floor staff by being an available GMP resource during shift changes and staff meetings.
- This position involves interaction with cross-functional departments within Technical Operations.
- Key factors in the function of this position are flexibility, good organization, time management, solid tracking and follow up, and being self motivated to make continual progress with minimal supervision.
- Demonstrate a full understanding of basic cGMP expectations; set a good example in observance of cGMP policies
- Interact with the Manufacturing floor staff regularly to answer questions related to GMPs and champion a compliant work environment
- Work with the Manufacturing Technical and Compliance Support team to evaluate and implement global CAPAs, regulatory/audit commitments, and general improvement projects
- Investigation ownership of Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
- Timely closure of Trackwise record (within 30 days for Devs, QEs) is a critical aspect of this responsibility
- Ensure timely progression of Material Holds and Impact Assessments during deviation investigations
- Investigate deviations; work with cross-functional groups to complete deviation reports and close incidents in a timely manner, while providing a framework for meaningful CAPAs
- Meet due dates for CAPA closure
- Provide training as needed
- Managing Change Requests (CRs)
- Work with Manufacturing staff and QA Change Control to contribute to comprehensive implementation plans for CRs
- Product Change-Over
- Work with Manufacturing leadership and staff to coordinate and organize product change-over activities and recommend future improvements.
- Training responsibilities
- Responsible to complete all training on time
- Work with Manufacturing supervisors and managers to ensure cGMP compliance with respect to training of Manufacturing staff.
- When working on clinical products, support and track records supporting GLP activities as well as technical experiments performed during tech transfer.
- Acquire fundamental knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification operations
- Comply with cGMP Documentation & Operations
- Compliance with safety guidelines
- A Manufacturing Quality Specialist works with cross functional groups to support the necessary production of products produced biologic from vial thaw through drug substance. Their contribution to this effort is to support the production staff in Quality and the cGMPs, thoroughly investigate deviations, and to prevent recurrence of deviations through effective CAPAs. The Quality Specialist also contributes to these efforts through training, documentation, and change control work as needed. Emphasis is placed on minimizing adverse impact to production quality or continuity of production.
- BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing
- MS in a technical discipline (physical or biological sciences preferred but not required) with 2+ years related to pharmaceutical manufacturing
- 4+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency at validation and/or change control (with BA or BS in biological science or engineering)
- 2+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency at validation and/or change control (with MS in biological science or engineering)
- Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred
- Ability to speak, present data, and defend approaches in front of a variety of audiences
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations
- Organizational skills to contribute to cross-functional projects
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications
- Familiarity with change control and related FDA & European regulatory requirements, guidelines, and recommendations
- The employee may frequently be required to sit and talk or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.