Quality Assurance Specialist

Job Description

Position Description:

This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance Representative for the Downstream (Blend, Fill and Lyophilization) Integrated Production Team (IPT). This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMPs.

This position will serve as the Quality Point of Contact for any quality issues the Downstream IPT has.  Additionally, this role will serve as the Quality Assurance Representative on Downstream Quality Systems Records.  These records include Deviations, Change Controls, SOP updates, Batch Record updates and more.

This team member will be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management.  They will report on site metrics, assist in prioritization and execution of Quality Compliance actions assigned to the IPT, and assist with Downstream batch record review on an as-needed basis.

This position will also serve as the primary back-up Quality Assurance Representative for Maintenance and Engineering assisting in the approval of qualification and validation documents on equipment and software systems.  Additionally, they will review and approve calibration records and assist with non-conformance related issues.

Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role.

A successfully candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Site System Owner of Sterile Media Simulation

• Requirement for Aseptic Gowning Certification

• Perform and assist with Internal Self-Inspections

• Help provide coverage for absences throughout the QA department

• Key participant in Quality Compliance Inspections from off-site entities.

• Other tasks as assigned by QA Manager and Quality Director

Education Minimum Requirement:

• Bachelor’s Degree (in the sciences preferred)

Required Experience and Skills:

• Minimum of five years of Quality experience in a regulated industry.

• Strong communication skills both written and verbal.

• Experience with investigations, risk assessment, and regulatory inspections.

• Skilled in technical writing.

• Candidates have experience in SAP and Various Quality Systems

Preferred Experience and Skills:

• Familiarity and/or experience with Downstream vaccine manufacturing

• Strong Maintenance and Engineering background

• Familiarity and/or experience with USDA regulations and inspections

• Project Management experience

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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