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Quality Systems Specialist

Application Deadline: March 31, 2020


Job Summary / Overview:
We are seeking a candidate with experience preparing technical documents in an FDA or other regulated environment to support the company Quality program.
This individual will provide Quality Assurance support for product life cycle management and will support the existing quality systems. Responsibilities including writing policies and procedures, GMP documentation change control, training, customer complaint support, participating in the annual product review, performing audits, and benchmarking cGMP requirements to ensure compliance with regulations. This position may require up to 10% out of state or out of country travel.

Key Duties & Responsibilities:
• Review, compile, track and trend information supporting Annual Product Reviews for Sagent products, including communication with internal departments and external CMO to assemble the required APR information
• Collect data in support of partner Annual Product Review reports
• Manage the Customer Complaint program by collecting information from customers, coordinating investigations with Contact Manufacturing Organizations, writing investigations, and entering information into the TrackWise® System
• Gather information and support investigations in support of required Field Alerts and Recalls
• Coordinate the processing and maintenance of policies and procedures for company compliance with regulations. Assist with creation and routing of changes in Veeva Vault
• Distribute new/revised procedures for training, ensuring on time employee completion
• Manage the electronic Learning Management System
• Support the Management Review process by compiling, and trending quality data
• Monitor outside vendor audits including scheduling audits, pre-audit call, review audit reports and downloading audit records from vendor database
• Report audit findings to suppliers, monitor supplier responses and corrective action
• Enter audit findings and supplier responses in TrackWise
• Perform selected domestic supplier audits
• Route Quality Agreements for approval
• Act as Business Owner & Subject Matter Expert for TrackWise®, Veeva Vault, and ComplianceWire systems
• Perform an estimated 5-6 Sagent Internal Audits annually
• Support regulatory inspections by acting as subject matter expert and audit administrator or scribe during FDA inspections

Knowledge, Skills and Abilities:
• In depth understanding of the Pharmaceutical industry regulatory environment
• Proficient with electronic quality management systems for complaints, change control, and training
• Possess strong writing skills to create various Quality Systems documents/records
• Ability to negotiate, influence and problem-solve in a matrix environment
• Possess strong organizational skills for prioritizing workload and responsibilities
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Possess organizational and project management skills to support quality improvement projects
• Proficient with PC-based word processors and spreadsheets

Minimum and Preferred Qualifications:
• At least 3 years of progressive challenging QA/QC experience in the pharmaceutical or medical devices industry
• In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines
• Preferred Qualifications: experience with preparing and managing technical documents and processes

Education / Certifications:
Bachelor of Science degree in Chemistry, Biology, Pharmacy, or related science field

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