SUMMARY:

The Quality Assurance Associate should be detailed oriented and will have responsibility for performing a variety of tasks related to Quality Assurance systems and compliance programs supporting GxP activities. This position requires experience working in GxP regulated environments and practical knowledge in FDA and international regulatory requirements as applicable to development and investigational phase products.    

RESPONSIBILITIES:  

• Assists in reviewing, processing, and maintaining company's Document Control system through:

• Organization and maintenance of controlled documents.

• Assisting in reviewing and processing Standard Operating Procedures (SOP), Forms, Reports, and equivalent documents through the Document Control system.

• Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.

• Performs regular follow-ups and tracks deviation investigation reports to closure.

• Performs regular follow-ups and tracks Open CAPAs to closure.

• Performs regular follow-ups and tracks open change controls to closure.

• Assists with executing and maintaining Electronic Document Management Systems as it relates to Quality.

• Assists with generating and providing Quality metrics.

• Assists in electronic and paper GxP records archiving.

• Batch Record Review

• Performs other related duties as assigned.

GENERAL RESPONSIBILITIES:

• Operates to the highest ethical and moral standards.
• Complies with company’s policies and procedures.
• Adheres to quality standards set by regulations and company's policies, procedures and mission.
• Communicates effectively with supervisors, colleagues and subordinates.
• Ability to participate effectively as a team player in all aspects of company's business.
• Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.

SKILLS, EDUCATION AND EXPERIENCE: 

• BA/BS in Health Sciences or related field preferred.
• A minimum of 3 years of Pharma/Bio-Pharma experience in the quality assurance field
• Batch Release experience required.
• Document Control/Records Management experience required.
• Demonstrates a thorough knowledge of GxP regulations and guidelines.
• Excellent written and oral communication skills and interpersonal skills.
• Ability to effectively manage multiple projects.        
• Must be proficient in Microsoft Office applications

AVAILABILITY: 

• Monday thru Friday 8 am to 5 pm with availability to work evenings and weekends, as required

POSITION LOCATION AND/OR TERRITORY AND TRAVEL 

• Position is located in Irvine, CA

POSITION TYPE

• Temporary to permanent hire position

Required Skills Required Experience