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Form of workSr. Specialist / Specialist Global Data Management | Just. - Global Quality Systems| Remote
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading GlobalQuality Systems (QS) activities related to Metrics, Trending and Key Performance Parameters (M,T and KPI), Quality Management Review (QMR) for the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
Responsibilities:
Educational Requirements:
Preferred Qualifications:
The base pay range for this position at commencement of employment is expected to be $76,000 to $120,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading GlobalQuality Systems (QS) activities related to Metrics, Trending and Key Performance Parameters (M,T and KPI), Quality Management Review (QMR) for the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
Responsibilities:
- Subject Matter Expert (SME) for all global QS activities related to M, T and KPI, QMR functions at Global level to assure compliance with quality and industry regulatory requirements.
- Collaborates with GxP business process owners (BPOs) and Subject Matter Experts (SMEs) to review written procedures in order to create M, T and KPI, QMR process structure and enhance training program.
- Reviews the site-specific M, T and KPI, MN, QMR process processes and procedures to ensure compliance with the Global process.
- Participates in the development and deployment of M, T and KPI, QMR process tools.
- Develops, communicates, and delivers training regarding process or system changes.
- Supports internal and external client audits and regulatory inspections. Including but not limited to SME for document control and document retrieval during regulatory inspections.
- Performs routine and ad hoc metric reporting and analysis for the Global and sites data related to M, T and KPI, QMR processes.
- Provides communication as to the status of deliverables to customers, management and stakeholders.
Educational Requirements:
- Bachelor degree in biological or engineering science with 3+ years relevant Quality experience and 5+ years experience in industry.
Preferred Qualifications:
- Project management experience.
- Good interpersonal skills to collaborate with team members globally.
- Strong computer skills including Microsoft Office and eQMS databases.
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making.
The base pay range for this position at commencement of employment is expected to be $76,000 to $120,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
