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Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc. This includes time and attendance review and maintenance for all department employees. Ensure all SOPs are current, and training on SOPs and processes remains current. Analyze Production efficiencies downtime and waste. Lead
Posted 4 days ago
Adhere to Standard Operating Procedures and GMP’s. Manually load components into unit cartons, pouches, shippers, etc. on an assembly line. Staging components and loading hoppers on assembly line. Accurately perform and document Quality Inspections, In Process Cosmetic Inspections, and Batch Record related information (verification of components and critical copy). Perform line clearances an
Posted 18 days ago
Provides support for special projects with the maintenance and engineering departments; including the validation team. Identify areas of improvement and implement. Work with Packaging leads and supervisors to organize human resources for these activities. Also support as a backup lead, as necessary. Qualifications Provide leadership role to the Accessories and Packaging operations. Oversee packagi
Posted 18 days ago
The Filling Operator is responsible for controlling the filling line including parameter setup, purging, and running production according to Standard Operating Procedures, Aseptic Technique, Bill of Materials, and Batch Records. Operates the Aseptic Filling Process and equipment to aseptically fill solution product into sterilized bottles. Monitors and inspects product during the filling process a
Posted 26 days ago
CMO product release activities include Review of all CMO warehouse receipts and product release documentation to ensure release compliance. CMO release requires a working knowledge of JDA (warehouse management system), PeopleSoft and ERPLx (inventory systems). Document Management activities including Initiation of Document Change Requests, maintenance of the document/SOP database, monitoring of pr
Posted 26 days ago
Observe, operate & troubleshoot Accessories equipment to ensure the manufacture of quality products to meet standard production quantities or better. Accessory manufacturing is primarily a manual operation. Accessory Assemblers cross train in other departments to increase workforce flexibility to address operational and business demands. Note Must be able to successfully cross train as a Package A
Posted 26 days ago
Works inside the APA on an assigned line/Line type and manages the operators assigned to that line. Coaches, develops and mentors employees in areas of responsibility and supports development of employees’ skills Reviews product batch records on the fill line for accuracy of entries, compliance to established limits and product specifications, and verifies presence of all verification signat
Posted 29 days ago
Maintain the APA in accordance with SOPs and within environmental monitoring limits by cleaning and sanitizing all equipment and rooms inside and adjacent to the APA. Document all cleaning and sanitization processes according to SOPs. Perform CIP and SIP processes for Fill Room Equipment. Install and test filters as required. Maintain the APA in orderly conditions by removing culls, performing reg
Posted 29 days ago
COMPLIANCE Ensure the department maintains compliance with cGXP, ISO 9001/ 13485 guidelines and assist with safety and ethical audit compliance. Develop and maintain internal audit schedules. Conduct internal audits as required to meet current regulatory and Global Quality expectations. Assist Supplier Quality Auditor, as needed. (May require some domestic or international travel). Establish, main
Posted 4 months ago
Successfully complete a formal training and certification program for all responsible products in the areas of product knowledge and selling skills Meet or exceed territory sales objectives. Develop an effective teamwork relationship with other B+L representatives in the sales region. Support the company’s mission of “Providing the World’s Most Valuable Ophthalmic Experience&rdqu
Posted 5 months ago
Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices. Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters. Oversight of validation activities for R&D trials and new products. Support engineerin
Posted 6 months ago
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