Job: Compliance Specialist 1

Job Scope:

Part of Quality and Compliance oversight and function of a cGMP sterile fill manufacturing operation. Ensure products manufactured are according to FDA’s regulations and cGMP to be pure, safe and effective. Provide leadership and support for continuous improvements via system improvements, non-conformation investigation, and implementing Corrective and Preventative Actions. Possess proven technical writing and problem-solving skills as well as a desire for developing investigators in the art of problem-solving analysis. Full-time position within a clean/temperature controlled environment throughout the entire facility. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Oversight of the Manufacturing Operations’ and Laboratory Controls’ deviation, OOS, complaint investigation and ensure non-conformance investigations meet or exceed the internal, customer and regulatory reviewers
• Routinely analyze investigations and CAPA performance to Management team for transparency and drive accountability for non-conformance closure and escalation of adverse trends
• Train and mentor investigators to conduct comprehensive investigations to determine root cause, product impact and implement corrective and preventative actions
• Conduct site-wide training on i.e. consequences and outcomes of deviations and investigations
• Track and trend Quality Metrics
• Participate in FDA and customer audits
• Other duties as assigned.

Job: Compliance Specialist 2

Job Scope:

Part of Quality and Compliance oversight and function of a cGMP sterile fill manufacturing operation. Ensure products manufactured are according to FDA’s regulations and cGMP to be pure, safe and effective. Provide leadership and support for continuous improvements via system improvements implementation. Possess proven technical writing and problem-solving skills to drive changes and provide documentation. Full-time position within a clean/temperature controlled environment throughout the entire facility. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Lead in continuous improvements of cGMP Compliance culture, for example GDP, GLP, Document and Trend Review, Change Control and implementations
• Conduct Risk Assessments for topics such as new product introduction, quality systems evaluations, equipment selection
• Provide guidance and support in qualification and validation activities, such as writing protocols and final reports, executing validation studies, training support staff in execution activities
• Conduct site-wide training on GMP’s, to include new-hire orientation training, and maintain training record
• Participate in preparation, documentation, and submissions to the FDA and CVM
• Participate in providing responses to regulatory agencies regarding product information or issues
• Bring together staff of different disciplines and drive the group to plan, formulate, and agree on comprehensive quality procedures
• Participate in FDA and customer audits
• Perform internal and external audits
• Perform Annual Product reviews
• Drive and support Right-First-Time work culture
• Other duties as assigned.

Job: Chemist

Job Scope:

Develop, perform, and implement methods to expand chemical testing of components, finished products, and environmental controls. Develop and execute protocols to satisfy current compendia methodology and GMP requirements. Ensure methods and protocols meet USP and CGMP requirements within a GMP aseptic fill manufacturing facility. Full-time position with a 5-day work week within a clean/temperature controlled environment throughout the entire facility. Paid uniforms. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Solve assignment and projects where analysis required in-depth evaluation of multiple factors and interactions. Exercise judgment within generally defined practices.
• Act independently on a routine basis on routine tasks and under supervision on new assignments
• Chemical testing for component testing, in process testing, finished product testing, sample analysis, physical evaluation of products environmental controls, and investigations
• Maintain notebooks, data, reports, and organized procedures for GMP understanding; effective data review
• Secure and order necessary supplies for laboratory work
• Assist in business development. Manage and carry-through assigned projects, i.e., research, bench top studies, stability, reporting, and follow-through
• Assist in decision making of analytical method selection, equipment and instrument purchasing, method development, and validation. Prepare draft reports for management.
• Subject Matter Expert of the implementation of chemical methods; responsible for establishing and revising these documents and training of these procedures
• Back up position for Laboratory Control Technicians Level II and Level III
• Other duties as assigned

Job: Project Scientist

Job Scope:

Coordinate efforts associated with the management function for existing and new projects and activities. Assist in the preparation of product development and regulatory documents and application for federal and state submission. Facilitate obtaining, updating, evaluating, compiling, and maintaining information and documents from internal and external sources for regulatory submission, registration, and license renewals. Research and interpret current regulations and guidance to facilitate their implementation. Maintain contemporaneous notes and catalog appropriately. Full-time position with a 5-day work week within a clean/temperature controlled environment throughout the entire facility. Paid uniforms. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Coordinate efforts associated with the management function for existing and new projects and activities
• Facilitate the update of the Veterinary Master File and Site Master File. Manage letters of authorizations/references
• Federal and state license renewals
• CVM/CVM Drug Listing
• Coordinate and communicate with customer for CMC related transfer and development activities
• Interact with customer/drug sponsor for submission documentation support
• Maintain, update, and communicate work progress and timeline impacts
• Support internal and external qualifications and validation studies
• Facilitate in process assessment and implementation. Facilitate gap analysis, identification, and mitigation
• Provide customer APR and batch record. Coordinate customer change requests and notifications externally and internally. Manage and assess supplier change notifications
• Facilitate in component and material sourcing, negotiation and supplier qualification
• Cross trained on Quality System III responsibilities
• Other duties as assigned