Quality Specialist
Quality Specialist
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Job Description
Job Title: Quality Specialist
Location: Newark CA
Type: 6 Months Contract
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.
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.
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:
Bachelors 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.
Employment Type
Full Time
