Operations Associate II
Proclinical is currently recruiting for an Operational Associate for a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for managing the quality interface with packaging and testing partners for clinical small and/or large molecules, early to late phase for finished drug products.
- Ensure efficient and effective use of time to support priorities and drive for results
- Oversee quality aspects of GMP activities for clinical product packaged, stored, and distributed. Activities include product disposition, quality support packaging operations, exceptions management, change control, risk management, technology transfer and validation
- Provide Quality expertise to influence tactical decisions needed to package and disposition product in a compliant manner to GMPs
- Support initiatives to improve systems/processes in Global Quality with a goal of compliance, efficiency and standardization
- Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections
- Perform tasks and makes decision consistent with cGMPs, and GDPs
- Collect and perform trend analysis for KPIs
- Additional duties as assigned
Skills and Requirements:
- BS degree in life sciences, engineering or related field preferred
- 2+ years pharmaceutical manufacturing, packaging, or laboratory experience including 5+ years in clinical and or commercial quality operations.
- Experience in quality operations as it relates to unit operations for the manufacture of either one or more of the following modalities: Parenteral, Oral Solid Dosage Form, ASOs.
- Experience working with third-party GMP vendors.
- Comprehensive knowledge of GMP and GDP regulations and subsequent applications to pharmaceutical drug manufacturing, and or packaging and distribution.
- Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations.
- Experience in contributing to regulatory filings and inspections preferred.
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 Zachary Hines at (+1) 215-531-6914 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.