Quality Product Support Analyst II

MedStar Health; San Diego (CA); On-site; Full time

Job summary

A leading healthcare company in San Diego is seeking a Quality Product Support Analyst II to ensure quality compliance and facilitate product support processes. The candidate will perform laboratory tests, manage data, and contribute to continuous improvement efforts. This is a full-time role with opportunities for professional growth and skill development.

Qualifications

• Minimum of 3 years relevant laboratory test experience, including QC/testing in medical device or diagnostic industry.
• Knowledge of quality regulations and standards.
• Experience with data analysis and trending.

Responsibilities

• Perform testing and interpret results according to SOPs.
• Document data accurately and completely.
• Support product quality investigations and maintain compliance.

Skills

Analytical skills

Critical thinking

Attention to detail

Communication skills

Data analysis

Problem-solving skills

Laboratory techniques

Education

Bachelor's degree in biology, biochemistry or related fields

Tools

Laboratory instruments

MS Office

Job description

Job Information

Number

ICIMS-2025-9012

Job function

QA&RA

Job type

Full-time

Location

San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States

Country

United States

Shift

1st

About the Position

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

The Quality Product Support (QPS) Analyst II is responsible for performing routine and non-routine assignments in support of the Quality Product Support activities as well as contributes to the achievements of the department and Werfen Autoimmunity Quality objectives. Ensures all responsibilities are carried out in accordance with established standard operating procedures (SOPs), policies and applicable regulations and standards.

Responsibilities

Key Accountabilities

• Performs testing, interprets test results, and other laboratory responsibilities according to Standard Operating Procedures (SOPs), protocols, test plans, and product instruction for use for stability studies, and investigation purposes.
• Performs routine equipment maintenance according to established procedures.
• Documents data, analyses, and information to generate records accurately, completely, and contemporaneously in accordance with Good Documentation Practices.
• Supports simple to moderate product quality investigations.
• Performs and documents out of specification (OOS) investigations.
• Supports testing for new product developments/design changes, validations, special projects, and qualifications/re-qualifications.
• Manages the maintenance of stability test articles/samples inventory.
• Maintains supply inventory levels and performs material ordering.
• Gathers, evaluates, trends data from product stability monitoring and other quality product inputs.
• Participates in continuous process improvement activities.
• Assists in maintenance of product stability studies schedules.
• Assists in maintaining work environment in state of compliance for GMP, OSHA and other applicable regulatory requirements.
• Assists in completion of monthly metrics.
• Embodies Werfen values and aligns daily actions with department goals and company culture.
• Other activities as deemed necessary by management.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Quality Control
• Quality Assurance
• Quality Engineering
• Manufacturing
• Operations
• R&D
• Regulatory Affairs
• Product Complaints

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor's degree in biology, biochemistry or other related fields required.
• Miniumum of three (3) years of relevant laborory test experience required, of which at least 1 year should be in medical device or in vitro diagnostic industry preferrably in quality control / product testing related functions functions.
• Working knowledge of data analysis and trending.
• Working knowledge of quality regulations and standards required, including ability to apply compliance and quality requirements.
• Working knowledge of laboratory practices and product testing in regulatory industry.
• Working knowledge of the scientific thinking.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Working skill in the operation and maintenance of laboratory instruments.
• Working analytical, critical thinking and problem-solving skills.
• Advanced proofreading accuracy and attention to detail skills.
• Advanced communication skills; both written and verbal.
• Advanced computer skills with proficiency with MS Office programs.
• Advanced observation skills.
• Advanced good laboratory techniques.
• Working ability to analyze and interpret data.
• Working ability to write in a concise, logical fashion.
• Working ability to effectively utilize scientific information resources within the assigned area of responsibility.
• Advanced ability to work effectively, both independently, and as an integral contributor toward the achievement of project and company goals.
• Advanced ability to work independently and within a team environment.
• Advanced ability to successfully manage multiple tasks in a fast-paced environment in a team and/or individual capacity.
• Advanced ability to follow procedures and protocols.
• Advanced ability to work in a methodical and organized fashion.

Travel Requirements:

• None

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate.

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The hourly range for this position is currently $24- $32. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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