Quality Associate I BHCJP00017387 Baxalta Milford, MA Duration: 12 Months Description
As a member of the Quality Assurance Operations team in Shire’s Milford, MA, biomanufacturing site, the Quality Associate reviews documentation and reports for conformance to procedures, protocols and regulatory requirements. The Milford site is a CGMP facility, responsible for manufacturing Obizur, a biologic treatment for Acquired Hemophilia A. The Quality Associate is part of the team that ensures that CGMP requirements are met and that only the highest quality product is produced and released. • Review batch records in real-time in the core manufacturing suite, with the goal of reducing product cycle time. • Review pertinent documents, records and reports such as Manufacturing Batch Records (MBRs) and batch packages against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines. • Administer and maintain relevant databases, preparing and issuing reports as required. • Assist in audits by maintaining audit records, extracting data from databases, collecting relevant data, and writing reports. • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet GMP, corporate, division, and site regulatory requirements. QUALIFICATIONS Minimum of Associate’s degree with 1-3 years of related Quality Assurance experience. Bachelor’s degree is preferred with QA experience in a CGMP environment preferred. Demonstrated knowledge of FDA regulations, specifically the application of Good Manufacturing Practices. Strong knowledge of manufacturing processes and the impact of deviations on the quality of the product. Exceptional attention to detail. Excellent interpersonal skills including the ability to work across departments and with people at all job levels. Demonstrated ability to make independent judgments and defend positions. Must be a strong team player with good problem solving, good verbal and written communication skills, and the ability to juggle multiple / rapidly-changing priorities. Vinay Kumar - Talent Acquisition Executive *KCS* *(*Keshav Consulting Solutions) . 1000 Bearcat Way Suite 105 Morrisville, NC 27560. Direct : 919-278-7724 Email ID: vi...@keshavconsulting.com Website: www.keshavconsulting.com <http://www.google.com/url?q=http%3A%2F%2Fwww.keshavconsulting.com&sa=D&sntz=1&usg=AFQjCNF93qZrjxju58n9mZNX7wcFf5owTw> -- You received this message because you are subscribed to the Google Groups "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at https://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/d/optout.
