Senior QA Specialist
Proclinical is currently recruiting for a Senior Quality Assurance Specialist for a biotechnology company located in Newark, CA. Successful candidate will primarily support the Supplier Quality program and Equipment Qualification program across clinical and commercial operations.
- Review, assess, and coordinate audit questionnaires in accordance with vendor management and monitoring program.
- Review and approve validation life cycle documentation including executed protocols.
- Review and approve Instrument/Equipment Master Records, Work Orders and Out of Tolerance (OOT) records.
- Review and approve quality system records (e.g. Deviations, CAPA, Change Control, etc.)
- Participate in developing and improving Standard Operating Procedures to ensure quality objectives are met.
- Perform a wide variety of activities to ensure compliance with applicable quality objectives, current Good Manufacturing Practices (GMPs) and applicable regulatory requirements.
- Work directly with operating entities to ensure that compliance commitments are met on a continuing basis as specified to enforce requirements.
- Apply company policies and procedures to resolve a variety of moderately complex issues.
- Exercise good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action.
- Keep abreast of requirements for compliance in own area of work. Participate as required in training on regulatory issues affecting own area of work. Notify manager of compliance questions and issues.
Skills and Requirements:
- BA/BS or equivalent combination of related education and experience.
- 7+ years' relevant experience in the pharmaceutical/biotech industry or equivalent combination.
- Experience in internal/external audits and equipment validation is preferred.
- Demonstrate 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.
- 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.).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.