Quality Assurance Professional - Pharmaceutical
Position: Quality Assurance Specialist
Reporting To: Director, QA
The Quality Assurance Specialist is a crucial role in conducting all aspects of Quality Assurance within NBPI GXP operations. Ensure GXP compliance both internally and external to the organization with contracted service providers. He/she is responsible for managing, coordinating, facilitating and implementing quality assurance standards based on ICH, European and FDA requirements across all NBPI products. The incumbent in this position writes quality assurance SOPs and policies, develops and controls early stage quality programs, monitors contractor/CRO conformance with QA standards and procedures and sets their direction for regulatory compliance. Approximately 10% travel is required. Additionally, provide guidance to in-house individuals and teams on Quality policy as it relates to their job.
Major Job Functions
- Strong technical writing ability
- Experienced with US regulations for early stage product, including GCP and GMP
- Strong organizational skills, task oriented, excellent time management skills
- Ability to multi-task; flexible and adaptable to changing priorities
- Works well with limited supervision and as a team member
- Effective communicator. Demonstrate the ability to negotiate assigned tasks with staff
- Apply company values of Sense of Crisis, Speed and Communication to tasks. Meets established timelines.
Specific Duties and Responsibilities
- Serve as the primary quality assurance resource for problem identification, resolution, loss reporting and continuous improvement.
- Track, coordinate and participate as necessary in qualification or audit process of vendors and CSPs
- Participate in teleconferences with CSPs and complete actions
- Champion the Nitto Denko goals when working with CSPs
- Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
- Report to management on quality issues, trends and losses.
- Interact with SMEs to assure completion of Nitto Denko required actions with CSPs, especially CMC and AD
- Provide Quality perspective and guidance for GCP studies and GMP compliance to Nitto Denko staff
- Author, edit, revise, approve SOPs, POLs, and forms as directed or needed.
- Obtain all documentation necessary for qualification of vendors and materials
- Perform quality function in eDMS (Workflow Coordinator in GXP workflows) to author, review and approve Standard Operating Procedures and associated documents
- Work with other QA employees to maintain compliant SOPs and Policies in eDMS
- Review Contracted Service Provider (CSP) records and procedures as provided. Perform QA review and provide feedback to CSPs.
- Perform batch record review and approval.
- Assist with non-GMP in-house Quality operations
- Initiate or approve in-house investigations. Document investigations as required by procedures
- Proficient in Microsoft Office Suite (e.g., Outlook, Word, Excel, PowerPoint)
- Core team member on CMO project development teams to provide QA support
- Assist and support QA Director as needed
- Ability to determine methods and procedures on new assignments and may provide guidance and training to other personnel.
- Additional tasks as required
Education, Licensure and/or Experience
- Bachelor's degree in Biomedical, Biology, Chemistry or Molecular Biology & 5 years experience in Quality Systems, Quality Assurance and/or Quality Control in Pharmaceutical or allied field
- Experienced with third-party contractors or as a third-party contractor
Experience with paper-based and/or electronic Document Management Systems (eDMS) in a regulated environment
- GXP in-house training experience
- GLP compliance experience
- Certification in Quality Assurance (pharmaceutical)
Physical Job Requirements:
Office/Lab environment. Lifting up to 50 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Disclaimer: This job description reflects management's assignment of essential job duties; and nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Nitto BioPharma, Inc., is a biopharmaceutical company focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Clinical assets include their first anti-liver fibrosis drug program (ND-L02-s0201), which is now in Phase 1b/2 trials in the US, Europe, and Japan. Nitto BioPharma is also advancing several programs for intractable diseases including Oncology and fibrosis. Along with the establishment of the new company in April 2016, in mid-2016 Nitto BioPharma moved into our new R&D facility on Science Center Drive in San Diego, California.
San Diego, CA
Thu, 5 Oct 2017 16:30:51 PDT