Quality Product Support Analyst II

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

 

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