QA Specialist ( "Product Quality Complaint Handling" experience is must )

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Position Title: QA Specialist I/II

Reports to: Manager, Quality Assurance - Quality Systems and Compliance

FLSA Status: Non-Exempt / Temporary (6-month Contract) / Hybrid (Newark, Ca)

Hybrid -1 to 2 weeks

Newark, CA

6+ Months

Interview process:

2 rounds

Purpose of the role:

This role will provide QA support for Quality Systems and Compliance, with a primary focus on QA oversight of all Product Quality Complaints. The incumbent will work closely with functional teams to ensure that all product complaints are reviewed, processed, and communicated in a timely manner.

Duties include, but are not limited to, the day-to-day handling of quality complaints and other QA activities that ensure the effectiveness of the Pharmaceutical Quality System.

Notes from client call:

QA Specialist 2 - Product Quality Complaint Handling

100% complaint handling

Key Responsibilities:

• Maintain high-quality documentation practices, ensuring compliance with Good Documentation Practices (GDP) and GxP requirements.
• Utilize electronic systems (VIVA or similar platforms) to handle complaint investigations and track progress. Experience with VeevA is a plus.
• Generate weekly matrix reports on the status of complaints, ensuring progress is monitored and communicated to the team.
• Handle complaints related to commercial products and collaborate with the CMC team (subject matter experts for formulation and production) for resolution.
• Address adverse events and patient-related complaints, obtaining additional information as needed, and cross-linking data between teams to ensure a thorough resolution.
• Manage the preparation and distribution of complaint letters to patients, which may require onsite work to print and send letters.

Job description:

Team: One full time employee

Position Responsibilities:

• Manage for all product complaint handling activities, from complaints receipt to closure.
• Record and process quality complaint information into the Product Complaint system, ensuring compliance with regulatory requirements and established procedures.
• Perform or coordinate complaint investigations, evaluate information from a technical perspective, and initiate corrective actions as needed.
• Conduct follow-up with reporters, cross functional departments and call center to gather additional information and issue response letters regarding product complaints.
• Review daily processes to ensure timely escalation of issues and communicate with management and team members to ensure appropriate actions are taken.
• Maintain accurate and current complaint documentation and ensure timely completion of tasks while adhering to quality standards.
• Identify and support process improvements to enhance efficiency and compliance in complaint handling.
• Perform other related duties as assigned based on company needs.

Position Requirements:

• Bachelor s degree or higher in a related scientific field or equivalent experience.
• 3-5 years of experience in a Quality environment, with demonstrated knowledge and proficiency in Quality System requirements.
• Practical understanding of CFR Title 21 (Parts 11, 210, and 211).
• Familiarity with FDA regulatory requirements, guidelines, and recommendations for product complaints.
• Broad experience with Quality Assurance systems and processes.
• Strong leadership, technical, management, attention to detail, problem-solving, and project management skills.
• Excellent communication, organizational, and interpersonal skills.
• Ability to present data, speak confidently, and defend approaches in front of audiences and inspectors.
• Experience with industry-standard enterprise system applications (QMS, EDMS).
• Proficiency in word processing and spreadsheet applications.
• Good knowledge of Good Documentation Practices (GDP) as they relate to complaint filing.
• Ability to work in a highly detailed environment, where mental focus and accuracy are essential.