QA Specialist - Perm - Rochester, MN
Proclinical is looking for a proactive, reliable, and experienced quality assurance specialist with outstanding interpersonal and technical skills for a growing biotech company. This company's mission is to provide innovative solutions to support viral, genetic, and cell-based therapies to improve patient quality of life worldwide.
They are a leading provider of viral and cellular products and research services with a focus on viro-immunotherapies. The company also provides correlative testing for clients who perform oncolytic virus clinical.
Primary Responsibilities:
The successful candidate will be part of a team providing viral and cellular products and research services, with a focus on viro-immunotherapies and correlative testing for oncolytic virus clinical trials.
Skills & Requirements:
- Bachelor's degree in quality assurance or science-related field.
- Minimum of 5 years in GxP or equivalent regulatory environment.
- Excellent knowledge of GLP and GCP requirements.
- Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
- Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.
- Able to understand published methodology to audit existing test methods and ensure accuracy.
- Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.
- Experience performing quality process audits and review of deviations and CAPA.
- Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).
- Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.
- Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
- Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
- Background in molecular biology, virology and/or serology is a plus.
- Contract research organization (CRO) experience is a plus.
- Experience with eQMS (Qualio) is a plus.
The QA Specialist's responsibilities will be:
- Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.
- Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.
- Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.
- Review all documentation for adherence to organizational quality standards.
- Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.
- Provide QA support of change controls, deviations, investigations, CAPA's and effectiveness checks.
- Develop and maintain compliance-related trending metrics and reports.
- Makes appropriate recommendations for correction and improvement as may be necessary.
- Provide oversight of personnel training record management.
- Provide QA support of internal and external audits, as assigned.
- Reviews and updates Quality Assurance procedures.
- Maintains audit forms and QA records.
- Other duties as needed.
Compensation:
- USD 75 000.00 - 80 000.00 per annum
If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com
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.
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