The Analytical Cleaning Validation Specialist is responsible for performance of Environmental Monitoring, Process Cleaning Validation, Process Cleaning Verification, and Clean Hold Dirty Hold Time Studies from Development to equipment release, including assisting with the establishisment, execution, and maintenance of compliant programs. The Analytical Cleaning Validation Specialist is responsible for activities at the Bangor and Stroudsburg facilities.

The Associate VP of Supply Chain Management is responsible for managing the supply chain operations of BioSpectra. He/she manages Logistics, Purchasing & Inventory Control and must step in to provide hands on support to their team when needed. The Associate VP of Supply Chain will continue to grow our systems and policies while expanding training and functional responsibility of his/her team to focus on Global Procurement Strategies and long-term business solutions.

The Chemical Operator will run all chemical manufacturing processes in compliance with all associated quality systems. Packs and ships all products. Maintains processes in their validated or compliant state.

The Construction Mechanic II will perform construction projects and repairs for all BioSpectra facilities properties.

The Data Integrity Specialist is responsible for monitoring and reporting on BioSpectra’s compliance with Data Integrity including but not limited to ALCOA+ principles, Computer System Assurance and Validation, and the most recent guidance documentation and regulations established for all paper-based and computer-based systems used by BioSpectra for cGMP processes.

The Director of Manufacturing Systems will oversee activities required for the successful execution of Process Technologies projects, provide recommendations to Leadership, and assist with training Manufacturing personnel in both the how & why as production processes are transferred to Manufacturing.

The Director of Quality Systems is responsible for creating and implementing the quality management system applicable to each BioSpectra facility. This position is responsible for communicating the expectations of BioSpectra’s CAPA management program. The Director of Quality Systems is responsible development and achievement of BioSpectra’s quality system objectives and ensuring BioSpectra processes and systems are compliant with established quality standards.

The Electrical Manager will oversee and coordinate the installation, qualification and maintenance of electrical equipment and utilities for all BioSpectra facilities and properties.

The Electrician will install, maintain, test, troubleshoot and repair electrical controls for all BioSpectra facilities.

The Electrician Assistant is responsible for assisting Electricians with installing and maintaining electrical systems.

EHSS Technicians are responsible for maintaining safe and secure workplace by reviewing employee compliance with BioSpectra EHSS programs, policies, and procedures, auditing BioSpectra facilities for compliance with Regulations, Policies, and Best Practices, Providing incident response support, verifying the security of BioSpectra facilities, processing Hazardous Waste, inspecting PPE & Safety equipment for operational readiness, participating in employee engagement programs, and taking action to fix non-conformances. Additionally, they secure and safeguard the facility and surrounding areas by observing and communicating suspicious activity, assisting with investigations, maintaining paperwork, logs and other required documentation, and appropriately executing emergency response procedures.

The Executive Coordinator will manage calendars, make travel arrangements and prepare expense reports. A Master Scheduler helps the President and other executive leaders stay organized by managing their schedules and keeping up with correspondence based on their needs. Will act as a point of contact among executives, employees, clients and other external partners

The Manufacturing Planning Specialist is responsible for participating in the implementation of the ERP software system by developing the tools to plan manufacturing and purchase the required products. This position will support the Director of Manufacturing by determining manpower, equipment, and products required to meet manufacturing demand. In addition, this position will create and process manufacturing transactions in the ERP software systems to support the manufacturing functions.

The Manufacturing Support Technician provides dedicated support to manufacturing operations and the production environment through the cleaning of production rooms and equipment as well as preparing needed materials for use in manufacturing areas.

The Manufacturing Technical Writer Supervisor is responsible for overseeing, authoring and revising manufacturing documentation including standard operating procedures, reports, cleaning procedures and batch records. The Manufacturing Technical Writer is responsible for ensuring manufacturing documentation is accurate and that document practices are in compliance with cGMP standards.

The Process Cleaning Validation Manager is responsible for all aspects of Cleaning development and Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program. The Process Cleaning Validation Manager is responsible for the Bangor and Stroudsburg sites.

The Process Statistician is responsible for ensuring the suitability of BioSpectra’ s manufacturing processes from system implementation through continued process verification. This position will perform process trend analysis for annual product reviews, verification of suitability of equipment and manufacturing system assessments to ensure optimal process performance.

The Process Validation Manager is responsible for the validation of products and processes at each BioSpectra facility. This responsibility includes the development and execution of the validation program that complies with BioSpectra policies, Industry standards, and applicable regulations. The Process Validation Manager is also responsible for ensuring that each process is maintained in a state of validation through periodic assessments and revalidation plans.

The Product Development Manager is responsible for designing suitable processes for consistent commercial manufacturing to obtain a product meeting the intended quality attributes. The Product Development Manager is responsible for the development, planning and evaluation of new processes at BioSpectra.

The QA Technician (Shop Floor) is responsible for assisting and supporting Quality Assurance activities on the manufacturing floor. This position has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, investigations, and corrective and preventative actions.