Mark Staniszewski Email & Phone Number

Coventry, Ri, Us

Coventry, Ri, Us

Cambridge, Massachusetts, Us

Thousand Oaks, Ca, Us

As a Sr. Associate working in the group within the manufacturing services organization, you will be required to work under minimal supervision This individual will possess the knowledge to successfully perform the tasks as follows:1. Create and maintain accurate daily, weekly, and monthly production schedules2. Facilitate daily scheduling meetings.3. Ensure current schedule is maintained, accurate, and up to date.4. Maintain excellent lines of communication with production and support staff.5. Provide emergency scheduling solutions and scenarios due to production/facility related issues.6. Proactive communication regarding scheduling errors and issues – provide realistic solutions.7. Track, analyze and report scheduling metrics on schedule adherence, task adherence, and root cause analysis as required.8. Configure, maintain, and test Electronic Batch Records9. Assist in implementing continuous improvement solutions 10. Conduct training and share knowledge with other members of the teamHands on experience with Werum PAS|X Understanding of basic cGMP as it relates to computer based systems Understanding of the overall Enbrel production process Experience authoring and executing validation scripts for GMP computer systems as well as a basic understanding of validation strategy Ability and willingness to train others on GMP systems for which you are responsible Organizational skills and an ability to perform assignments with a high degree of attention to detail Excellent written and verbal communication skills

Thousand Oaks, Ca, Us

Efficiently perform and monitor critical GMP manufacturing operations in accordance with Standard Operating Procedures (SOPs).Effectively use and perform basic troubleshooting within the site’s electronic systems (e.g., and Manufacturing Execution System (MES), Delta V, and Enterprise Resource Planning (ERP) system).Execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.Contribute to the culture of safety and quality by participating in and leading team safety and quality initiatives.Understand and contribute to the team’s Lean Manufacturing goals and objectives by identifying improvement opportunities and implementing solutions.Work with diverse teams.Escalate issues appropriately.Ownership of corrective and preventative action and non-conformance records

Thousand Oaks, Ca, Us

Responsibilities include but not limited to operation and set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, SAP, etc and cleaning and sanitization of production areas• They will perform all operations with due care and attention and in accordance with Good manufacturing practices and Amgen requirements.• They will be involved in problem solving and troubleshooting including initiation and documentation of investigations.• They will be responsible for the performance of self-inspection Quality & Safety Audits within their functional area.• They will be part of a learning and development program which will include annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process. They will be responsible for the cross training of other colleagues.• They will be responsible for the use, review, revision and upgrade of operational documentation and peer review of operations.• They will play a key role in the development of the manufacturing systems and will be responsible for continuous improvement initiatives. Proactively identifying operational improvement opportunities or process related issues.• They will be champions for safe working practices and safety initiatives within their functional area.• They will carry out any sampling, testing and inspections that may be required. They will carry out calibration and maintenance of test equipment.• Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.

Pigments and dyes facility

Education record

Education record