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The Senior Project Manager will coordinate a multidisciplinary project team to assure the accurate and timely completion of all contract writing and managing, ERP, invoicing, designing and implementing project plans, acting as the primary liaison with the project team and client communicating project information to appropriate staff members. The Senior Project Manager may serve as program manager and assist clients with their drug development programs. The Sr. Project Manager may also be called upon to participate in the corporate management process and shall actively engage in and support business development efforts.
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The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and supporting inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The Senior Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.
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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...
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The Sr. HVAC/R Technician is responsible for performing routine and emergency maintenance during business hours, unless otherwise notified of an emergency on Alcami’s laboratory and building refrigeration, air conditioning, and heating systems. Availability is required to respond to equipment emergencies. The Sr. HVAC/R Technician is the Subject Matter Expert (SME) responsible and accountable for preventing excursions for CTUs. This includes providing guidance to end users as well as assisting with design and maintenance. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each by yourself and team...
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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. 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 position develops SOPs or other quality documents as needed.
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The Senior Manufacturing Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, mechanical and electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Manufacturing Maintenance Technician operates in a highly technical fast paced environment requiring experience related specifically to keeping production business running. The Sr. Manufacturing Maintenance Technician applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other...
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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).
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The Sr. Scientist I, Microbiology is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assisting in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and cleanroom qualification efforts. The Sr. Scientist I, Microbiology participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Sr. Scientist I, Microbiology may serve as a primary technical contact with clients.
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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.