Specialist I, QA Compliance

Emergent Biosolutions•Canton, MA

1d•$129,000 - $156,000•Onsite

About The Position

The Specialist I, QA Compliance is responsible for independent QA oversight of each Quality System in support of commercial product manufacturing at the site and manages activities for one or more Quality System or cross-functional project. The Specialist I, QA Complance will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management.

Requirements

Bachelor’s Degree in Scientific or related fields
A minimum of six (6) years of cGMP Quality experience
Strong Commercial manufacturing experience (Large Molecules) required
Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
Expert Knowledge and application of GMP principles
Excellent communication skills: oral/written and listening
Excellent facilitation and presentation skills
Critical analytical skills, strong verbal and communication skills
Must be able to critically evaluate data summaries and conclusions
Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
Ability to influence without authority across cross-functional organization

Nice To Haves

Quality Auditor, Six Sigma, or equivalent certification/education preferred

Responsibilities

Represent the department in interactions with internal functional units and external contract partners or regulatory officials
Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
Support Supplier Quality Program including conducting Supplier Audits, as assigned
Develop and revise Quality Technical Agreements and supplier notification of changes to ensure impact is thoroughly assessed prior to implementation and liaise on investigations of nonconformities for suppliers providing products or services in support of GMP operations
Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
Plan, schedule and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan
Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems
Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team
Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.