The Senior Quality Assurance Specialist, GMP Manufacturing is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling...

The Visual Inspection Technician I is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.

The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...

The Senior Materials Management Coordinator is accountable for driving results in a fast-paced environment by facilitating the log in of laboratory samples and the projects the lab will use for documentation of the analysis. This position provides administrative and organizational support related to materials management activities. The ideal candidate will maintain documentation and files to assure they are accurate and up-to-date and available to appropriate personnel.

The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Associate Director, Laboratory...

  The Scientist I (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist I (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).  

The Manager, Facilities and Maintenance is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and...

The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. These activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Specialist serves as quality host for client and regulatory agency audits and inspections. The position develops SOPs or other quality documents...

The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The position will perform the role of Lead Inspector for external audits and act as consultant with clients for all level of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.

The Packaging Technician I is accountable for driving results in a fast-paced environment by inspecting, labeling and packaging of solid dose and parenteral pharmaceutical products for commercial distribution and clinical trials. The Packaging Technician I will operate inspection and packaging-related processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices.

The Senior SAP PTM/EWM Functional Specialist is accountable for driving operational excellence through the optimization of SAP S/4HANA processes, specifically in the Plan-to-Manufacture (PTM) and Extended Warehouse Management (EWM) areas. This position plays a critical role in supporting and enhancing our SAP landscape following our recent go-live on RISE with SAP. The ideal candidate will serve as the functional subject matter expert, partnering with business and IT stakeholders to stabilize, support, and evolve our manufacturing and warehouse systems.

The Director, Pharma Storage is accountable for driving results in a fast-paced environment. The Director, Pharma Storage is a client-facing position responsible for regional oversight on behalf of the Pharma Storage department providing leadership and mentorship to all operations personnel within the region.   The Director, Pharma Storage ensures that Pharma Storage activities are executed in compliance with industry regulations, data integrity, and the quality management system. This leadership role manages short and long-term goals of the operation and implements and manages projects to ensure deadlines are met.   This role acts as a point of...

The Calibration Field Technician II is proficient in multiple disciplines at customer sites and is able to work independently. The Calibration Field Technician II will set up equipment, perform calibration on various instruments including, but not limited to, temperature, relative humidity, CO2, voltage, pressure, time, rotation, mass, etc. following documented procedures using precision standards. Calibration and preventive maintenance will be performed in-house or off-site based on business needs.

The Sr. Environmental Health and Safety Specialist develops, implements, and sustains EH&S programs at the cGMP Operations, and at manufacturing, laboratory, and warehousing facilities. The Senior EH&S Specialist ensures the safety of all employees, visitors, and contractors, protection of the environment, and maintenance of compliance with all Federal, State, and local regulations. Reporting to the Senior Management in Operations, the Sr. EH&S Specialist works closely with the Corporate EH&S Director as well as other EH&S team members to ensure program alignment across the larger Alcami organization.

The Sr. Reporting and Analytics Analyst is responsible for leading the strategy, development, and delivery of enterprise reporting, analytics, and AI capabilities across platforms such as SAP SAC, Power BI, and Microsoft Fabric. This role is accountable for helping develop, deploy, and maintain SAP applications. This role is expected to help deliver accurate, scalable, and insight-driven solutions to support business decision-making. This position owns the end-to-end lifecycle of BI and AI applications — from data integration and modeling to visualization and automation and ensures alignment with organizational goals, data governance standards, and evolving technology trends. In addition, this role is responsible for enabling AI adoption by operationalizing...

The Lead Visual Inspection Technician is accountable for results in a fast-paced environment and responsible for performing tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Lead Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Lead Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning, and provides training and coaching to less experienced Visual Inspection Technicians as required. The Lead...

The Manufacturing Technician II (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Tech II is a key role responsible for executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Tech. II performs the operation of...

The Business Development Sr Manager - Pharma Services is accountable for the sales of the company’s pharma support services (IQ/OQ/PQ Validation and Calibration) within the defined territory. Duties include lead generation, creating sales opportunities, growing the sales pipeline and winning new business as well as expanding business with current customers.

The Lab Informatics Specialist will be responsible for evaluating and improving the Waters NuGenesis system, which is used by the Laboratory Services business unit. The Lab Informatics Specialist will collect and analyze data to then identify and implement effective solutions. This role will develop, configure, and customize the system, while working collaboratively with various departments to understand requirements and maintain data integrity.

Alcami is seeking a proactive and results-oriented Business Development Manager/Sr. Manager to join our team in the West Coast region. This position is accountable for driving results in a dynamic and fast-paced environment by increasing sales and revenue for assigned business segments, specifically Analytical Testing and Development Services. The ideal candidate will possess a scientific background including laboratory or pharmaceutical manufacturing experience with a proven track record of sales experience in the pharmaceutical, biotech, or CDMO industries. This individual is highly inquisitive and motivated, a self-starter with a tenacious drive and ability to generate new business prospects, with a demonstrated ability to maintain and grow strategic customer...