139 other jobs found in Jeffersonville, OH

Alkermes, Inc. *This position is located in Wilmington, Ohio Summary: Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation Job Description : Read and follow detailed written SOPs / Procedures Document all work as required by cGMPs on a timely basis Executes tasks as directed with close attention to detail Monitors Process with close attention to detail Abide by all safety requirements as defined by the company Can work independently...

Alkermes, Inc. Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation Job Description : Read and follow detailed written SOPs / Procedures Document all work as required by cGMPs on a timely basis Executes tasks as directed with close attention to detail Monitors Process with close attention to detail Abide by all safety requirements as defined by the company Can work independently without constant supervision Follows Alkermes internal...

Alkermes, Inc. This is a temporary position. To inspect the GMP (Good Manufacturing Practices) vials - product and glass vials - for defects. Perform label and packaging activities for finished product. KEY DUTIES: Inspect vialed product and empty glass for defects Perform daily process activities in compliance with standard operating procedures (SOPs) Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas. Assist in writing and implementing area's process documents Operate equipment in compliance with SOPs Assure compliance with cGMP requirements (current good manufacturing practices) Work non-routine hours as required to maintain production schedule Perform label and packaging activities for finished product Complete and review associated production records and daily trending Train new inspectors in accordance with vial inspector certification procedures Assist other manufacturing...

Alkermes, Inc. GENERAL DESCRIPTION: The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff. KEY DUTIES: Perform testing in accordance with written procedures (i.e. USP/EP/JP grade) Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices. Processing of electronic data using procedures that ensure data integrity and security. Ship samples to contract testing facilities. Entry of test results from contract laboratories Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity...

Alkermes, Inc. POSITION SUMMARY The position is to support the ongoing commercial manufacturing effort in Wilmington. The position will be important in establishing and maintaining GMP-compliant manufacturing systems. They will work with production personnel to ensure documents and production records comply with GMP. They will play an integral part in ensuring the manufacturing systems and documents are GMP-compliant and audit and inspection-ready MAJOR RESPONSIBILITIES Work with Team Leaders and Supervisors to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production). Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing personnel. Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development Review completed GMP documentation...

Alkermes, Inc. Summary Alkermes is seeking a Process Automation engineer for our Wilmington, OH site responsible for providing support for control systems related to Manufacturing, Clinical, Utilities, Lab, and Pilot Plant Operations. Job responsibilities include maintaining standard software applications and custom modifications, resolving application issues, conducting application training and development of related SOPs, and supporting software system validation in a GMP environment. Essential Functions Assist in the planning, development, and deployment of Process Automation control system solutions Apply knowledge and support for 21CFR part 11 and Good Manufacturing Practices Write documentation and assist with the validation of control systems Provide manufacturing run-the business support including some after-hour on-call coverage Execute change controls and applicable maintenance of related control systems Requirements Engineer I Required...

Alkermes, Inc. This position will provide direct leadership on the assigned shift in the manufacture of commercial product. Manage multi-disciplined teams in a pharmaceutical production area to ensure all manufacturing systems, production processes, equipment and final pharmaceutical product meets or exceeds Alkermes manufacturing standards, regulatory requirements and business objectives. Responsibilities: Acts functionally as the operational leader on the floor during the shift with direct responsibility for Manufacturing Associates and operations executed by that shift. Provides effective, 'hands-on' leadership to the production team as a whole, including Team Leaders and Manufacturing Associates, across all shifts in the production of pharmaceutical drug product. Plans and supervises daily execution of tasks to support published production plan and supervises completion of work through the Team Leads Supports the Line Manager in complying with identified...

Alkermes, Inc. POSITION SUMMARY High-level position for persons to manufacture commercial scale batches. MAJOR RESPONSIBILITIES Lead other operators and small groups as directed by the Supervisor. Production, filling, and inspection of pharmaceutical formulations. Assist with facility cleaning and operational maintenance. Assist with facility and process validations as required. Perform aseptic production operations and validations. Assist with environment and water system monitoring as required. Assist with clean room sanitization as required. Assist with RCRA and safety inspections as required. Document all work as required by CGMPs on a timely basis. Read and follow all company SOPs and guidelines. Abide by all safety requirements as defined by the company. Train newly qualifying personnel. Provide coaching and feedback for currently qualified personnel. Other tasks as assigned by the Supervisor. COMPETENCIES...

Alkermes, Inc. Description This position will be responsible for delivering first class service, advice, and technical support to our users, through the highest standards of customer service, efficiency, knowledge, and integrity. This individual should have experience architecting and implementing Global Networks with multiple underlying technologies. Work with network team to assist with resolving the daily operational issues for all sites. Strong background in supporting High Availability GxP MFG IT/OT environments. This individual will work with Service Operations Mangers predominantly outsourced on the stability and integrity of mission critical infrastructure, applications, and systems. This position will ensure adherence of provided IT Network Management Services to the business as per agreed SLA's. This is a site-specific role where the incumbent will be the first point of contact for business and IT contacts at the Alkermes Wilmington site for initiatives requiring...

Alkermes, Inc. Summary The Lead Category Specialist role is responsible for the execution of predefined strategic sourcing processes for Construction and Capital Equipment and ensures adherence to policies and procedures. The individual in this role will proactively address and resolve routine variations within the defined strategic sourcing processes, including but not limited to: issues related to supplier performance, documentation, delivery execution, pricing, and / or quality. The individual will also participate in the refinement of sourcing strategies and improving sourcing patterns to improve Alkermes financial performance. Essential Functions Develop relationships with internal customer base to better understand their procurement needs while leveraging best value through strategic sourcing opportunities. Educate and train customer base on sourcing policies, processes, and systems. Administer the end to end purchase order process, supporting Finance,...

Alkermes, Inc. Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation. Job Description : Read and follow detailed written SOPs / Procedures Document all work as required by cGMPs on a timely basis. Executes tasks as directed with close attention to detail. Monitors Process with close attention to detail. Abide by all safety requirements as defined by the company. Can work independently without constant supervision. Follows Alkermes internal...

Alkermes, Inc. Position Summary: Alkermes is seeking an experienced SAP Supply Chain Solutions Analyst to play a key role in our upcoming S/4 implementation. This position will bridge technical expertise with business process knowledge to transform our supply chain operations. This position is a key member of the SAP Team and will also serve as the primary liaison between the SAP Team and the local SAP super users across all functions. In addition, this individual will lead and manage related business and systems initiatives from a technical perspective. The role will be based in Wilmington, OH (hybrid) and will require up to 25% travel during the implementation and infrequent travel after. Locations include Waltham, MA (primary) and Ireland (Dublin & Athlone). Essential Duties and Responsibilities: Partner with the SI to lead the design and implementation of SAP S/4 supply chain functions. Map current business processes to target future state processes,...

Alkermes, Inc. This position is based in Wilmington, OH Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: Read and follow detailed written SOP's/MPR's/Procedures. Document all work as required by cGMP's on a timely basis. Execute tasks as directed with close attention to detail. Monitors process with close attention to detail. Follows Alkermes internal policies. Abide by all safety requirements as defined by the company. Perform Aseptic Gowning...

Alkermes, Inc. This position is based in Wilmington, OH Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: Read and follow detailed written SOP's/MPR's/Procedures. Document all work as required by cGMP's on a timely basis. Execute tasks as directed with close attention to detail. Monitors process with close attention to detail. Follows Alkermes internal policies. Abide by all safety requirements as defined by the company. Perform Aseptic Gowning...

Alkermes, Inc. The Quality Control Chemistry Team Leader/QC SPECIALIST V will be the technical leader responsible for the technical work for a small group of chemists performing testing to meet QC cycle times and to comply with all Alkermes criteria and cGMP regulations. He/she will apply knowledge, experience and initiative in resolving highly complex non-standard problems and developing recommendations. Responsibilities: Recognize and takes ownership when problems occur, makes necessary decisions and escalates as necessary. Communicates decisions to wider group and follows up to ensure compliance with decision. Accountable for all people management, technical and scheduling issues in the absence of the supervisor. Leading and participating in improvement projects. Lead Root Cause Analysis process and write up within department complex issues, identify the solution and implement. Monitor the effectiveness of preventative measures and has the ability to...

Alkermes, Inc. POSITION SUMMARY In the assigned manufacturing area, directly supports the Aristada Manufacturing Process. Actively supports ongoing manufacturing efforts in terms of quality and efficiency, provides an interface with Development and Engineering in technology transfer of new processes and process upgrades to existing technologies, and supports Corrective and Preventive Action programs. Conducts real-time monitoring/trending of manufacturing processes and finished product analytical data. MAJOR RESPONSIBILITIES Develops and maintains databases that provide trending capability for process parameters. Develops and maintains (tracks) Aristada production metrics using analytical tools. Conducts frequent and thorough periodic reviews of the database and trends, identifying opportunities for improvement in performance in process, manpower effectiveness, and efficiency. Actively identifies unfavorable trends and investigates root cause as well as...

Alkermes, Inc. This position is based in Wilmington, OH Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: Read and follow detailed written SOP's/MPR's/Procedures. Document all work as required by cGMP's on a timely basis. Execute tasks as directed with close attention to detail. Monitors process with close attention to detail. Follows Alkermes internal policies. Abide by all safety requirements as defined by the company. Perform Aseptic Gowning...

Alkermes, Inc. GENERAL DESCRIPTION: The QC Analyst II performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst II may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff. KEY DUTIES: Perform testing in accordance with written procedures (i.e. USP/EP/JP grade) Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices. Processing of electronic data using procedures that ensure data integrity and security. Ship samples to contract testing facilities. Entry of test results from contract laboratories Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data...

Harbor Freight Job Description A Retail Sales Associate (part-time) is a valued member of a high performing team who is empowered & equipped to do their job. You will know why your work matters and take pride in what you do! The anticipated rate for this position is $16.00 per hour depending on location, knowledge, skills, education and experience. Associates (and their families) are eligible to participate in a limited medical, dental, vision, basic life insurance, and short-term disability. Eligible Associates are able to enroll in our company's 401k plan. Associates can accrue paid time off up to 152 hours per year (inclusive of PTO, floating holidays, and paid holidays). Paid sick time up to 64 hours per year unless otherwise required by law. Respectful schedules during operating hours of 6am - 10pm. Why You'll Love it: People First Culture Paid time off Associate discounts Medical/Dental/Vision Insurance for all associates Company Matched 401(K) Respectful...

Adient The Materials Supervisor will supervise and coordinate the day-to-day activities of a team of workers to ensure that goods are moved, handled, and stored safely, correctly, and in accordance with established schedules and inventory lists. The Materials Supervisor will coordinate material control systems, inbound/outbound shipments, and materials handling activities and inventory control primarily from the shop floor. Coordinate all material handler activities. Coordinate activities for warehouse layout. Training, coaching, developing the material handling team. Implement and assist in development of cycle counting and pull system for each commodity. Manage/coordinate the receiving and DMR processes. Manage the input of incoming receipts on a regular timely basis. Manage the process of outbound shipments. Coordinate all customs compliance requirements. Observes Materials/Production operation within their area of control to ascertain Compliance with methods,...