Quality Systems Specialist

Overview

Responsible for duties associated with two or more Quality System processes, including: the administration, reporting and process creation / optimization / automation, while ensuring accordance with current good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP) and current Good Tissue Practices (cGTP). The processes comprising the Quality Systems include: Non-conformance / Investigations, CAPA, Change Control, Customer Audits, Supplier Audits, Training, and Supplier Qualification Program. Duties include effectively interacting with Testing, Manufacturing, Project Management and Quality Assurance personnel in order to deliver superior customer service. Acts as a back-up for the Supervisor when needed.

Responsibilities

• Administers assigned Quality Process. Duties include issuance of process tracking numbers and completion associated tasks according to established Standard Operating Procedures (SOP).
• Generates and maintains Quality data and associated metrics according to established SOPs.
• Reports Quality metrics according to established SOPs or by Management request.
• Leads team on improving assigned quality processes.
• Becomes the Subject Matter Expert (SME) for the assigned Quality processes.
• Authors and leads development / modification / improvement efforts associated with Quality SOPs.
• Ensures document maintenance is adhered to. (i.e.: biennial SOP reviews)
• Provides and prepares documentation and materials for/in various reporting forums for internal and external customers.
• Leads and/or participates in Quality System reporting forums assessing compliance with cGMP and other applicable regulations.
• Participate/Lead in quality and process improvement initiatives, and project teams.
• Conducts internal and client audits.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Works under close supervision from supervisor or senior personnel. Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Maybe required to work Overtime
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Perform other duties as assigned

Qualifications

• 3-5 years of relevant experience or equivalent
• Bachelors’ degree in a Science related field or equivalent experience
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook).
• Must be proficient in multitasking and time management.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
• Ability to use judgment as dictated by complexity of situation.
• Proficient in Oral & Written communication skills
• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time