Job Description

 Responsibilities:

• Develop and coordinate effective implementation of quality management system (QMS), quality orientated programs supporting R&D, production and customer complaints resolution. • Prepare quality plans, procedures and instructions for quality control and manufacturing in accordance with Repligen QA policies and ISO 9001 standards. • Initiate and track NCMRs, Deviations, and CAPAs. • Perform and assist in customer complaints and discrepant materials (NCMR) investigations etc. • Compile and analyze information/data related to nonconformance, deviation, corrective action, root cause, and customer complaint investigations. • Perform trend analysis of supplier, internal quality issues, customer complaints, NCMRs etc. for monthly KPIs and for Management Review meetings. • Monitor and assist in the department material review activities to ensure that established quality objectives are being met and that adequate procedures and work instructions are in place and are being followed. • Conduct, participate, and support internal quality audits, supplier audits, process/product improvement projects, supplier evaluation surveys, and disposition activities. • Assist in QC testing if required and review testing or manufacturing data. • Perform other relevant duties as may be assigned by management.

Qualifications:

• Bachelor’s degree Life Science/Engineering or relevant equivalent discipline. • 5 -7 years quality related experience in pharmaceutical or device industry. • Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem-solving are highly desirable. • Analytical decision-making skills to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. • Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulations and flow charts. • Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations. • Good written and verbal communication skills. • Interpersonal skills to interfaces with all levels of the organization, management, customers, and suppliers. • Experience in pharmaceuticals s or medical devices industry a plus. • Knowledge and experience of statistical analytical tools and sampling plans.

Company Description

Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany. Our Products Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes. As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies.