Quality Assurance Specialist

Hello,

Greetings from NexInfo!

We are hiring Quality Assurance Specialist with one of our direct pharma client located in Oceanside, CA for the onsite work agreement. Good fit please share your updated resume to ***email_hidden***

Role Description

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our Oceanside, CA site and report into the Sr. Manager of Quality Assurance Operations.

The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations

Key responsibilities

Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)

Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, nd Stability)

Approve shipments and provide oversight during packaging of product

Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls

Ensure timely assessment and closure of Laboratory Investigations

Ensure timely assessment and closure of batch and material hold events

Communicate lot disposition pending issues to Management

Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areas

Perform walk-throughs and process observations

Perform Document Control administrative activities including archival and updating of site training

records

Support Regulatory Body Inspections of the facility

Ensure products are manufactured in compliance with regulatory and GMP guidelines.

Escalate issues that may adversely impact timely release of product

Identify compliance risks and escalate the issues to appropriate levels of management for resolution

Generate and update procedures and forms as needed

Perform additional duties as needed

Qualifications

Master’s Degree and OR

Bachelor’s Degree and 2+ years’ experience in the biological sciences or related field OR

AA Degree and 4+ years’ experience in the biological sciences or related field OR

High School Degree and 5+ years’ experience in the biological sciences or related field

Quality Control background in Analytical, Virological, and Microbiological testing

Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards

Ability to effectively negotiate and build collaboration amongst individuals

Proficient in MS Word, Excel, Power Point and other applications. Experience with Veeva, Smartsheet and LIMS is highly desirable

Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Thanks, and regards,

Vijayakumar