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QA Specialist - II*
Job 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 (include but are not limited to):
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
Basic 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
Preferred Qualifications:
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
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 (include but are not limited to):
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
Basic 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
Preferred Qualifications:
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
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