VTI Life Sciences Sr. Quality Assurance Specialist in San Francisco Bay Area, California
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.
We are looking for a Sr. Quality Assurance Specialist to support the Supplier Quality program and Equipment Qualification program across clinical and commercial operations. Will assist in quality systems and compliance activities including but not limited to: deviations, CAPAs, change control, supplier quality and audit management. The role will be performing vendor audits primarily, and possibly review equipment validation documentation if needed, the ideal candidate would have to have recent external auditing experience of different types of vendors and be knowledgeable of applicable regulatory requirements.
- Reviews, assesses, and coordinates audit questionnaires in accordance with vendor management and monitoring program. * Reviews and approves validation life cycle documentation including executed protocols. * Reviews and approves Instrument/Equipment Master Records, Work Orders and Out of Tolerance (OOT) records. * Reviews and approves quality system records (e.g. Deviations, CAPA, Change Control, etc.) * Participates in developing and improving Standard Operating Procedures to ensure quality objectives are met. * Performs a wide variety of activities to ensure compliance with applicable quality objectives, current Good Manufacturing Practices (GMPs) and applicable regulatory requirements. * Works directly with operating entities to ensure that compliance commitments are met on a continuing basis as specified to enforce requirements. * Applies company policies and procedures to resolve a variety of moderately complex issues. Exercises good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action. * Keeps abreast of requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of compliance questions and issues.
- At least 7 years of relevant experience in the pharmaceutical/biotech industry or equivalent combination. * Experience in internal/external audits and equipment validation is preferred. * Works under limited supervision; demonstrating a level of independence and providing recommendations for continuous improvements. * Demonstrates proficiency in application of QA systems principles and standards, current industry practices, and applicable regulations including 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents. * Comprehensive knowledge of audit standard, practices and principles. Demonstrates ability to perform detail-oriented work with a high degree of accuracy. * Demonstrates excellent verbal, written, and interpersonal communication skills. * Effective time management, organizational and planning skills. * Possesses initiative and is proactive. * Builds productive internal and external working relationships. * Must work effectively within teams with rapidly changing priorities. * Demonstrates good coping skills and analytical problem-solving skills. * Experience with databases and has advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.). * BA/BS or equivalent combination of related education and experience.
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org