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Analyst II, Complaint Vigilance
The Analyst II triages and evaluates non-serious and serious product quality complaints and processes product quality complaints in accordance with Standard Operating Procedures using the Product Quality Management System. This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed. Analyst II will process complaint change logs and monitor group mailboxes for critical communications from business partners.
Analyst II collaborates with global partners in Consumer Care Centers, Medical Safety, Business Quality, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
The Analyst II must have the ability to assist with various projects within the department, communicate effectively with management. This role will query and analyze data and other trends from complaint systems.
Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
Processes non-serious product complaints according to internal Standard Operating Procedures. Performs review of complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed, in a timely manner. Ensures all relevant data for complaints are obtained. Collaborates with global partners in Consumer Care Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling.
Monitors Complaint Records in PQMS to ensure standard process is being followed and complaints are closed as required. Compile product and lot-specific complaint trending data and complaint closure metrics as requested. Supports internal and external audits and inspections for Skillman products.
Evaluates and assigns serious complaints to sites. Collaborates with internal and external sites to become familiar with product/manufacturing sites.
Assists with various projects and activities related to Central Complaint Vigilance process and system implementations and improvements.
DESCRIBE THE KNOWLEDGE, SKILL ABILITY AND EXPERIENCE REQUIRED:
A minimum of 3+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical, medical devices or other related or highly regulated industry.
• Experience working in an FDA regulated environment.
• Previous product quality complaint handling experience desirable.
• Possesses excellent verbal, written and listening communications skills.
• Written and verbal skills in Portuguese and/or Spanish are a plus.
• Strong knowledge of GMP Regulations, ICH and ISO guidelines including but not limited to: CFR parts 11, 210, 211, 820, and 803, ICH Q7, Q8 and Q9, and ISO 10002, 9001, 13485, and 14971.
DECISION-MAKING AND PROBLEM SOLVING:
Deals with issues using deductive reasoning, critical analysis skills and systematic approaches.
Thinks in a clear, decisive manner, remains calm under adverse conditions, and reaches reasoned decisions and solutions when required. Ability to manage multiple issues, prioritize and escalate to management when appropriate. Role must have critical thinking, collaboration skills and training ability.
Seeks to understand the latest trends and developments. Identifies business risks and needs. Able to understand/discern safety, business (legal), and compliance risks related to complaints and in achieving performance objectives. Delivers value-added business results through execution and controls.
Demonstrates intellectual/emotional capability and commitment and exercises a degree of adaptability in dealing with an ambiguous and complex work environment in a responsive and professional manner.
Proponent of the Pharmaceutical credo and central QA organization vision, mission and goals.
EXTERNAL AND INTERNAL INTERACTIONS:
Establishes good working relationships with colleagues and key stakeholders (external and internal). Communicates effective with global business partners in non-face to face interactions.
Analyzes data and other trends, and presents to department management. Interacts with global partners in Consumer Care Center, Manufacturing and quality personnel at internal manufacturing sites. Interacts with medical safety for investigation of adverse events with potential product quality issues. Provides support for internal audits and inspections by regulatory authorities.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS:
It is required for the incumbent to follow all safety procedures to minimize health hazards. Minimal (10%) travel is required; some possible overtime work may be required, dependent upon business needs.
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