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QA Release Specialist - Mt. Vernon

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This position will be based in Mt. Vernon, IN. The Commercial Quality Specialist manages product releases and holds to ensure that all product received and managed at the LC is handled properly to ensure Right First Time and customer service goals.

 

Key Responsibilities

• Ensures full compliance and sufficient throughput of workflow for product releases.
• Acquire and maintain a precise working knowledge of all cGMP’s, Operating Procedures, and all production documentation.
• Possess and communicate a working knowledge of LC and CMO processes and work flow.
• Analyze errors and deviation from process and procedures, responsible for holding key stakeholders accountable and provides guidance on key actions and steps required to correct deviations.
• Execute and lead all required and necessary activities to affect the release of lots.
• Maintain knowledge of WMS and JDE systems to accurately set status.
• Ensures that Hold Notifications are made to appropriate internal and external stakeholders.
• Participate in quality processes such as; Change Control, Supplier Management, Deviations and investigations, CAPA as needed.
• Identifies functional and process gaps and develops and deploys training to correct knowledge gaps.
• Maintain and assure the proper use of Documentation Systems, both electronic and paper based.
• Supports Environmental, Health, and Safety by monitoring LCs against company policies and procedures regarding EHS.
• Manages relationship with 3PL stakeholders and assures RB processes and procedures are followed.


Qualifications
• Minimum of a BA or BS degree, preferably in the life or natural sciences.
• 2+ years’ experience in Quality Assurance / Quality Control Systems in regulated environment.
• Must be quality focused and detail oriented.
• Must possess the competence to perform tasks requiring analytical and problem solving skills.
• Must produce a high caliber of work and exhibit an exceptional level of detail and accuracy.
• Must demonstrate outstanding teamwork in interacting with other team members, to create a harmonious teamwork oriented environment.
• Excellent written and verbal communication skills, problem solving, decision making and computer proficiency
• Experienced in Good Manufacturing Practices and Good Distribution Practices.
• Experience working in ISO14001:2004 environment preferred.
• Experienced in quality systems such as ISO 9000, GMP, HACCP, and Auditing.
• Demonstrated ability to work independently and handle multiple projects in a fast paced environment.

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.

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