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The Compounder I is an entry level position to Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures. This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use.
Perform Clean-In-place (CIP) and Steam-In-Place (SIP) functions as required by specific documentation or procedures.
Maintain work area and equipment on a daily basis to ensure compliance. Work area is maintained at level to sustain organization of supplies and equipment. Area is kept clean and sanitized as required by current and applicable procedures. Equipment is kept in an organized and compliant manor.
Introduction to compounding functions as deemed necessary by operations management and functions where qualified to perform.
Hourly pay rate in the mid to high $20's/hour
The ability to read, write and speak English is a requirement of the job.
Perform laboratory support functions such as sample log-in and storage, issuance of controlled data forms, and monitoring of temperature controlled chambers in compliance with standard operating procedures, safety, and cGMP regulations. Responsible for all associated documentation and for maintenance of stability storage area. laboratory area.
Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.
The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc
This is a union position and the hourly rate is $24.51/hour
The ability to read, write and speak English is a requirement of the job.
Quality Assurance Inspectors work “hands-on” on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors are responsible for sampling, inspection and physical testing of packaging components. Quality assurance Inspectors ensure procedures and documentation meet cGMP and Quality standards. As a key support member of a rapidly growing company, the QA Inspector must be flexible in their approach to work and be comfortable with taking on new challenges.
The ability to read, write and speak English is a requirement of the job.
The Senior Engineer - Technical Project Lead is responsible for managing strategic / technical engineering projects in a cGMP environment through planning, organizing, and controlling all elements of the project. Have the ability and competency to oversee all facets of the projects, inclusive but not limited to URS development, equipment procurement, installation, qualification and financial oversight. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-paced environment and the competence to concurrently handle multiple projects and operational initiatives. This position is exempt from overtime.
The Principle Engineer - Technical Project Lead is responsible for managing strategic / technical engineering projects in a cGMP environment through planning, organizing, and controlling all elements of the project. Have the ability and competency to oversee all facets of the projects, inclusive but not limited to URS development, equipment procurement, installation, qualification and financial oversight. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-paced environment and the competence to concurrently handle multiple projects and operational initiatives. This position is exempt from overtime.
The Janitor/Matron is responsible for keeping the building in a clean and orderly condition, in accordance with all SOPs and cGMP requirements.
Starting pay rate is $18.14/hour
The ability to read, write and speak English is a requirement of the job.
The Validation Engineer II is responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products.
Major job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, managing project timelines, and participating in cross functional teams.
The purpose of this role identifies basic technical problems, atypical results or methodology malfunctions and assists in the investigation to correct them. This role provides technical support for routine testing activities and conducts physical and chemical analyses of samples, products and materials. This role ensures notebooks and reports are in compliance with regulatory guidelines, completes projects within time limits and budgetary constraints, performing mathematical calculations, interprets results, records observations and responds to and assists in audits and investigations. The role is primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. The incumbent will provide guidance to junior staff members with respect to training.
The purpose of this position is to support the Company in the development and optimization of manufacturing processes, improving them and increasing the scale. The ultimate goal is to develop processes that optimize the product yield and minimize the cost of production. These products include injectables and nasal/sublingual sprays
The Metrologist is responsible for ensuring calibration compliance of all necessary equipment and instruments through understanding of guiding SOPS, instrument OEM manuals, and end user requirements. Supports manufacturing operations (sterile/non-sterile) by ensuring equipment/instrument calibrations are performed at point of use (aseptically as required) when the equipment is available and in a timely manner. Day to day responsibilities will include completing assigned calibration tasks, including paperwork, and troubleshooting basic equipment, implementing fixes as necessary.
The Training Coordinator is responsible for ensuring the effective and efficient implementation, coordination, facilitation and administration of cGMP training and qualification programs. The coordinator may do the training him/herself, train other staff members to conduct their own sessions or arrange for training through external providers.
The Sr. Assembler is an entry level position in an assembly and packaging environment in the pharmaceutical industry. Personnel in this role are required to perform basic manual functions at, or near, assembly and packaging machinery. Job functions within this classification will include interaction with products being assembled and packaged and are subject to strict quality and safety guidelines.
The Sr. Assembler is an entry level position in an assembly and packaging environment in the pharmaceutical industry. Personnel in this role are required to perform basic manual functions at, or near, assembly and packaging machinery. Job functions within this classification will include interaction with products being assembled and packaged and are subject to strict quality and safety guidelines.
The Sr. Assembler is an entry level position in an assembly and packaging environment in the pharmaceutical industry. Personnel in this role are required to perform basic manual functions at, or near, assembly and packaging machinery. Job functions within this classification will include interaction with products being assembled and packaged and are subject to strict quality and safety guidelines.
The Sr. Assembler is an entry level position in an assembly and packaging environment in the pharmaceutical industry. Personnel in this role are required to perform basic manual functions at, or near, assembly and packaging machinery. Job functions within this classification will include interaction with products being assembled and packaged and are subject to strict quality and safety guidelines.
The QA Specialist role is to review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures. They will release products, drug product components and container-closures, review and write cGMP procedures with minimal supervision as well as report periodic quality metrics.
The purpose of this position is to serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions
This will be accomplished largely through leading and conducting appropriate root-cause analyses for events and authoring investigation reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products.
The Project Coordinator directly supports Project Managers in the daily management of multiple projects for our healthcare partners. The size and scope of the projects assigned are large and complex, and usually consist of high profile development and/or launch activities. Specific responsibilities include the creation and maintenance of project timelines, budgets, resources, and documentation at the direction and under the supervision of the Senior Project Manager. As the secondary point of contact with our Healthcare Partners behind the Project Manager, the Project Coordinator maintains strong professional relationships with them through setting realistic expectations and timely communications. Project coordinators also perform various administrative tasks. These tasks include filing project documents, creating and maintaining project schedules, creating responsibility lists for those who are involved in the project, and compiling summaries for those who were involved.
The Facilities Maintence Mechanic will demonstrate a high level of Facility Maintenance ability and critical thinking skills, and aptitude for solving complex problems while demanding integrity, sense of urgency, accountability and attention to detail. This role will be on a 12-hour day shift.