- Catalent Pharma Solutions (Greendale, IN)
- …Quality Plan (FQP) standards. Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training. + Responsible for ... ensuring Dietary Supplement's Identity, Purity, Strength and Quality. + Participate in all necessary training is required to successfully perform job responsibilities. + Other duties as assigned. **The Candidate** + High School Diploma or GED required. BS in… more
- Catalent Pharma Solutions (Greendale, IN)
- …and implementation of the process systems. Ensures this work meets cGMP (current Good Manufacturing Practices) expectations. + Work with operations, validation, ... process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment. + Worksindependently and effectively interact with customers, design engineers, site… more
- Lilly (IN)
- …capital project controls, metrics, and governance. + Leadership experience in cGMP environments and manufacturing processes. Lilly is dedicated to helping ... individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (… more
- Lilly (Indianapolis, IN)
- …of experience supporting pharmaceutical manufacturing **Additional Skills/Preferences:** + cGMP Operations leadership experience + Experience in Statistical Process ... Control (SPC) and Six Sigma Tools (eg Green Belt certification) or Lean Tools + Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment + Capability to work in a virtual and complex environment across different… more
- Bristol Myers Squibb (Indianapolis, IN)
- …techniques, sterility assurance, and contamination control. + Thorough understanding of cGMP regulations, ICH guidelines, quality system, and safety guidelines. + ... Experience in sterile pharmaceutical manufacturing is required and experience in radiopharmaceuticals is preferred but not required. **Skills:** + Strong leadership, communication, and team management skills + Ability to drive continuous improvement and… more
- Unilever (Hammond, IN)
- …Procedures (SOP's) for Packaging. + Ensure that all department and factory cGMP 's are followed. + Collaborate with appropriate departments and support. + Evaluate ... and investigate material waste related to packing lines, creating robust action plans to drive waste reduction. + Build teams to solve problems and respond to concerns/ issues. + Communicate to all team members, scheduling and other members of management to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Skills and Qualifications * Expertise in pharmaceutical engineering, including cGMP and FDA/USP/OSHA regulatory requirements. * Proven experience developing and ... leading engineering teams. * In-depth knowledge and hands-on experience with radiopharmaceutical production, and related GMP facility site builds is desired. * Strong background in facility and utility systems, aseptic processing, and fill/finish equipment. *… more
- Berry Global (Princeton, IN)
- …Participating in Lean and Safety programs. + Following applicable Food Safety and cGMP polices. + Assisting in the training of fellow associates. + Performing other ... duties as assigned. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable… more
- Novo Nordisk (Bloomington, IN)
- …personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices ... + Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance + Product Quality + Accountable for review and approval of project related documents such as Master Batch Production Records, technical… more
- Novo Nordisk (Bloomington, IN)
- …to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments. Schedule self-performed work assigned ... at beginning of month and due by end of month + Follow general instructions on routine work and detailed instructions of new work + May design new approaches to problems encountered and use a wide application of complex principles, theories, and concepts in… more