Careers

Shift Supervisor, Manufacturing

The Shift Supervisor, Manufacturing is responsible for control of all GMP clinical and commercial bulk manufacturing and packaging operations assigned to them. They are responsible to ensure that all projects are executed in a compliant and efficient manner. They are responsible for managing the personnel assigned to their unit. They are intimately involved with the technical aspects of all assigned projects. The Shift Supervisor, Manufacturing ensures that their unit works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Xcelience

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QA Associate, Operations

The QA Associate will assist the Quality Organization with company compliance to the cGMPs, DEA, global, state and local requirements as it relates to the manufacturing, packaging and testing of clinical trial material as required per 21 CFR Parts 210 and 211 and other regulations. Support GMP/GLP activities relating to client projects by sampling incoming materials, organizing material and product retains, cleaning verification, and document tasks as per applicable SOPs. Have the ability to perform room inspections based on batch record requirements. Exercise independent judgment, within defined procedures and regulations, to provide decisions and guidance regarding compliance issues. Remain objective and maintain high standards of ethics, honesty and urgency required to meet the quality standards, objectives and goals of Xcelience.

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QA GxP Training Specialist

Quality System Process Owner/Support role with focus on Quality Training Programs. Supports the development, implementation, and maintenance of all aspects of Xcelience internal training system elements, including training processes (design, delivery, including trainer qualifications, documentation and training effectiveness) and curricula development and assignment. Supports the development and maintenance of the site-wide OJT training guidelines focused on cGMP/Quality/Compliance regulations.

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QA Specialist I, Operations

The QA Specialist I will assure company compliance to the cGMPs, DEA, global, state and local requirements as it relates to manufacturing, packaging and testing of clinical trial materials as required per 21 CFR Parts 210 and 211 and other regulations. Support GMP/GLP activities relating to client projects by reviewing protocols, reports, batch records, test methods, specifications, validation and qualification of equipment and SOPs. Exercise independent judgment, within defined procedures and regulations, to provide decisions and guidance regarding compliance issues. Remain objective and maintain high standards of ethics, honesty and urgency required to meet the quality standards, objectives and goals of Xcelience.

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Senior QA Compliance Specialist

The Senior QA Compliance Specialist will assure Company compliance to the cGMP’s, DEA, global, state and local requirements as it relates to the manufacturing, packaging and testing of clinical trial material and commercial products as required per 21 CFR Parts 210 and 211, EU, and other regulations. Support activities relating to client, third party audits and supplier/vendor audits.

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Preformulation/Formulation Chemist II

Works cross functionally within the department to provide preformulation or formulation development technical support to facilitate the successful completion of development projects.

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Manufacturing Technical Specialist

The Manufacturing Technical Specialist is responsible for technical support for all manufacturing operations. They are responsible to assist in ensuring that all projects are designed and executed in a compliant and efficient manner. They are intimately involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Manufacturing Technical Specialist works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Xcelience.

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Manager, GMP Manufacturing Services

The Manager, GMP Manufacturing Services is responsible for administration and control of all GMP manufacturing operations, including both commercial and clinical applications. They are responsible to ensure that all projects are designed and executed in a compliant and efficient manner. They are responsible for managing the personnel assigned to their unit. They are intimately involved with the technical and regulatory aspects of all projects from inception to completion. They ensure that their department works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Xcelience.

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Technician I, Operations

Perform cleaning of equipment, process rooms and facility. Perform equipment assembly/set-up and document entry activities. Perform and document tasks as outlined in applicable Standard Operating Procedures (SOPs) and Master Batch Records. Support process and facility operations by complying with company and FDA cGMP requirements.

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Facility Technician I (2nd Shift)

The Facility Technician I is responsible for the maintenance and function of equipment at all facilities. They are responsible for completing tasks assigned by the Facility Engineer. They are intimately involved with the technical and regulatory aspects of their areas and departments.

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Facility Compliance Specialist I

The Facility Compliance Specialist I is primarily responsible for ensuring the Xcelience’s US facilities are compliant with local, state, and national government agencies, with a primary focus on FDA regulations with respect to pharmaceutical facilities. The Facility Compliance Specialist will also serve as back up Subject Matter Expert (SME) in the Facility Manager’s absence with the ability to answer audit observations made by clients and government agencies.

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QA Compliance Specialist/Senior Specialist

The QA Compliance Specialist provides functional ownership for a portion of internal programs that assure company compliance to the following standards:

•US GMPs, as described in 21 CFR Parts 210 and 211

•EU GMPs, as described in Commission Directive 2003/94/EC and Eudralex Volume 4, Parts 1 and 2, and relevant annexes

•ICH quality guidelines, including Q8, Q9, Q10, and Q11

•WHO good manufacturing practices for pharmaceutical products

•PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-11

•US Drug Enforcement Agency regulations (if applicable)

•Applicable product licenses and applications

•Any other applicable international, federal, state or local regulations and guidelines

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Warehouse Technician I

To execute warehouse receipt, storage, issuance of material to production & perform distribution activities in compliance with cGMP guidelines. This will require on time and neat documentation during the execution to assure compliance.

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Analytical Team Leader

Lead, manage and help establish policies, procedures and systems for the Analytical Department/Formulation Development Department to ensure quality control of processes and products by performing the essential functions of the position.

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Facility Technician I

Responsible for the maintenance and function of equipment at all facilities.

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Technician III- Manufacturing

Perform cleaning, equipment assembly/set-up and document entry activities. Conduct and lead batch processes. Serve as certified trainer for all Tech I and Tech II- manufacturing equipment and procedures. Work cross-functionally within the organization to facilitate the successful completion of all development projects and meet the objectives and goals of Xcelience. Support process and facility operations by complying with company and FDA cGMP requirements.

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Chemist III

Xcelience is looking for a Chemist III to design and carry out analytical experiments to support preformulation, formulation and/or analytical projects that meet the scientific and regulatory requirements of a project. Must have Doctor of Philosophy degree in Chemistry.

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Chemist II

Work cross functionally within the department to provide analytical and technical support to facilitate the successful completion of analytical development projects.

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Formulator II

Work cross functionally within the department to provide formulation development and technical support to facilitate the successful completion of development projects.

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