Aseptic Processing Technician duties include: Provide support to sterile filling and compounding departments by completing parts cleaning, preparing parts and supplies for sterilization. This will be accomplished by operating autoclave and other cleaning and sterilization equipment, assisting with preparation of disinfectant solutions, cleaning of the aseptic process area (“APA”) including floors, walls, and equipment. Some tasks are performed in a class 10,000 area while others are performed in a non-classified clean room area. Various levels of PPE are determined by the location the task is being completed.

Job Responsibilities:

• Strict adherence to standard operating procedures (SOP) and good manufacturing practices (GMP).
• Clean rooms including floors, walls, and equipment, using aseptic techniques.
• Clean equipment and parts including disassembly/reassembly of parts as directed.
• Operate equipment to sanitize/sterilize parts, equipment, and components following standard operating procedures.
• Complete required logbook entries and associated batch documentation.
• Obtain materials, perform check-in procedures and associated paperwork.
• May assist with maintaining uniform stock for cleanroom garments; prepare, ship, and receive cleanroom garments.
• Appropriate personal protective equipment (PPE) must be worn in accordance with established procedures.

Job Duties and Responsibilities: Perform the operations and processes to manufacture sterile and non-sterile penicillin or cephalosporin products for human and veterinary use, including:

• Strict adherence to standard operating procedures and good manufacturing practices;
• Perform the prescribed inspection procedures, complete required calculations, and paperwork;
• Follow detailed instruction for assembly, disassembly, and set up of equipment;
• Perform required cleaning of the aseptic manufacturing facility and equipment;
• Assist with preventive maintenance as directed;
• Obtain raw materials, perform check-in procedures, accurately weigh/measure as required; calculate quantities, perform conversions as needed;
• Observe and maintain aseptic technique in a clean room environment.

Responsibilities include: Maintain all production equipment and facility systems in a reliable and safe operating condition through preventative maintenance. Troubleshoot, modify, and repair support systems and equipment as needed. Perform installation of equipment following standard operating procedures. Assist in the installation and commissioning of new electrical systems and PLCs. Stay current with technological advancements in PLCs to contribute innovative solutions to enhance manufacturing processes. Maintain accurate documentation of maintenance activities, including logs, reports, and work orders. Work with internal and external entities to complete repairs and improvements on plant facilities and equipment. Provide support, guidance, and training for co-workers as directed/needed.

Must understand the operation of production equipment and facility support systems to provide reliable equipment performance and minimal downtime through effective preventative maintenance, troubleshooting and repair. Coordinate downtime, troubleshooting, and repair with production departments. Perform preventative maintenance tasks and associated paperwork as assigned. Coordinate shutdown activities to ensure all planned activities are accomplished.

Proven experience as a Maintenance Mechanic in a pharmaceutical manufacturing setting. In-depth knowledge of Programmable Logic Controllers (PLCs). Familiarity with electrical systems, motors, drives, and instrumentation. Strong troubleshooting and problem-solving skills, with the ability to work under pressure. Excellent communication and collaboration skills for effective teamwork. Understanding of safety protocols and adherence to regulatory requirements. Flexibility to work in a dynamic manufacturing environment with rotating shifts if required.

May be required to carry an electronic device for 24-hour call-in. Must be flexible to work alternate shift/workdays when needed. Typical 1st shift schedule is 4, 10-hour days. Standard work hours for 1st shift are 6:00 AM – 4:30 PM. Alternative work hours/work schedule may be available dependent on business need.

Responsibilities include: Maintain all production equipment and facility systems in a reliable and safe operating condition through preventative maintenance. Troubleshoot, modify, and repair support systems and equipment as needed. Perform installation of equipment following standard operating procedures. Assist in the installation and commissioning of new electrical systems and PLCs. Stay current with technological advancements in PLCs to contribute innovative solutions to enhance manufacturing processes. Maintain accurate documentation of maintenance activities, including logs, reports, and work orders. Work with internal and external entities to complete repairs and improvements on plant facilities and equipment. Provide support, guidance, and training for co-workers as directed/needed.

Must understand the operation of production equipment and facility support systems to provide reliable equipment performance and minimal downtime through effective preventative maintenance, troubleshooting and repair. Coordinate downtime, troubleshooting, and repair with production departments. Perform preventative maintenance tasks and associated paperwork as assigned. Coordinate shutdown activities to ensure all planned activities are accomplished.

Proven experience as a Maintenance Mechanic in a pharmaceutical manufacturing setting. In-depth knowledge of Programmable Logic Controllers (PLCs). Familiarity with electrical systems, motors, drives, and instrumentation. Strong troubleshooting and problem-solving skills, with the ability to work under pressure. Excellent communication and collaboration skills for effective teamwork. Understanding of safety protocols and adherence to regulatory requirements. Flexibility to work in a dynamic manufacturing environment with rotating shifts if required.

May be required to carry an electronic device for 24-hour call-in. Must be flexible to work alternate shift/workdays when needed. Typical 1st shift schedule is 5, 8-hour days. Standard work hours for 1st shift are 8:00 AM – 4:30 PM. Alternative work hours/work schedule may be available dependent on business need.

Responsibilities of a Process Control Technologist include: design, conduct, and report validation studies for critical equipment and processes in a pharmaceutical manufacturing environment including IQ, OQ, PQ, Process Validation, and Cleaning Validation. Successful candidate will research processes, define critical variables and operating ranges, research guidelines and regulatory requirements, and write protocols in accepted format. Coordinate execution of validation studies with Production, QA, QC, and all other appropriate internal departments. Perform test runs in compliance with the protocol and complete proper documentation. Compile and analyze data collected during test runs, including laboratory test results. Review, interpret and analyze data. Create graphs, charts or tables and compile support documentation. Write validation summary reports. Complete Validation Confirmations, Continued Process Verification, and revalidation studies to maintain current validation status. Research documents and records needed to complete confirmations. Monitor and revise production documents for conformance with validations.

Pharmaceutical Production Associates duties include: Perform the operations and processes to fill and package non-sterile penicillin products for veterinary use. This will be accomplished by operating high speed production equipment, to include non-sterile filling, packaging, and labeling machines in a fast-paced environment. Some tasks are performed in a class 10,000 area while others are performed in a non-classified clean room area. Various levels of PPE are determined by the location the task is being completed.

Job Responsibilities:

• Strict adherence to standard operating procedures (SOP) and good manufacturing practices (GMP).
• Perform required cleaning of the non-sterile filling, packaging areas and equipment and completion of logbooks.
• Perform the prescribed inspection procedures, complete required calculations, and paperwork.
• Obtain materials, perform check-in procedures and associated paperwork.
• Appropriate personal protective equipment (PPE) must be worn in accordance with established procedures.
• Assist with preventative maintenance as directed.

Onsite training is provided in the QA Auditor’s job duties, which include: Perform in-house line audits of pharmaceutical filling and packaging operations; review manufacturing activities and documentation for compliance with SOPs; perform line clearances, in-process, and end-item inspections; review and apply specifications for acceptance of in-coming packaging components, raw materials, and finished products; generate, review, and issue batch production records; release materials & components for use in production; organize and issue printed materials to production; monitor & interpret charts and gauges; log book review, issuance, and archival. Successful candidates will be highly motivated, self-starters with knowledge of contemporary cGMP practices and procedures. Good written and oral communication is essential. Technical writing is a plus.

Scope of Position

Manage assigned staff to monitor the operations and performance of the Quality Assurance team. Ensure departmental operations and documentation comply with standard operating procedures, government regulations, and customer requirements. Ensure company programs comply with regulations, guidelines, and industry standards. Assist in maintaining budget and acting as liaison with both internal and external entities. Assist with recruiting and selection process for department.

Key Position Responsibilities

• Manage Quality Assurance Department – Provide guidance and support to supervisor in management of Quality Assurance team including overseeing team performance. Manage department to ensure team members are working toward company and departmental goals. Participate in performance management and other Human Resources related items. Manage operations of department among all company facilities and production shifts. Participate in recruitment and selection process.
• Documentation Review and Approval – Review and approve Production and Quality documentation including but not limited to Batch Records, Deviation Reports, SOP’s, Investigative reports, etc., to ensure completeness, accuracy and compliance with procedures, regulatory guidelines, and industry/customer expectations.
• Document Preparation/Revision – Prepare/revise SOPs, sample plans, and other production documents as required. Investigate and write reports, provide status reports and updates per procedure for deviation and investigation reports CAPA.
• Department Representative – Attend internal and external meetings as directed by Department Head to include management meetings, FDA and customer audits and inspections. Provide CAPA updates and input on departmental metrics.
• Acts as Departmental Liaison – Contact customer(s) on quality issues as applicable. May assist with customer and/or supplier audits. Act as liaison internally and cross departments.

The Quality Assurance Specialist- 3rd Shift, provides day-to-day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that production activities comply with cGMP standards, regulatory expectations, and safety requirements while enabling efficient, high-quality output.

Key Responsibilities includes:

• Provide floor-level technical support to manufacturing operators and supervisors.
• Troubleshoot equipment, process deviations, and workflow bottlenecks.
• Monitor production performance and assist with implementing corrective actions.
• Prepare, revise, and maintain GMP documentation including SOPs, batch records, and logbooks.
• Ensure adherence to FDA and other global regulatory requirements.
• Support investigations, CAPA development, and change control processes.
• Perform data collection and review for compliance and continuous improvement.
• Partner with Process Control to support equipment qualification and validation activities.
• Assist with process improvements, optimization initiatives, and technology transfers.
• Support preventive and corrective maintenance coordination with Engineering and Maintenance departments.
• Train manufacturing personnel on procedures, new equipment, and process changes.
• Act as a subject matter liaison between Production, Quality and Maintenance teams.
• Uphold and promote a strong culture of safety and compliance on the production floor.
• Support environmental monitoring and compliance activities as needed.