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ResponsibilitiesDuring the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral/Device Assembly and Packaging areas as well as lead / assist in operations readiness programs (e.g. Material procurement and definition, training programs, process excellence, continuous improvement, and capacity planning). The person in this role will be the technical subject matter expert and will be involved in hiring and training personnel. Once the facility is turned over to operations, the OA role is responsible for daily performance management and support of the process team. This individual must ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area.
Key Objectives/Deliverables

• Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Responsible for delivering the manual and semiautomated visual inspection training content to train and qualify operators.
• Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
• Lead/conduct area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Lead and facilitate operations readiness activities and programs for the operations portion of the business which includes consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility
• Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area
• Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.
• Lead area tours to support business reviews, regulatory audits, or network collaboration.

Basic Qualifications

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 2 years working within manufacturing/operations.
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA, or other similar groups
• Excellence in; electronic, written, and oral communication skills
• Strong technical aptitude as demonstrated through previous work or educational accomplishments

Additional Skills/Preferences

• Working within or directly supporting pharmaceutical, food, packaging, or applicable manufacturing departments
• Highly automated equipment (inspection, filling, device assembly, packaging, etc.)
• Advanced computational capabilities (e.g. Data Analysis, Pareto and Control charting, Trending and computing with multiple variables)
• Technical writing such as creation of standard operating procedures, work instructions, and training documentation.
• Facility, Equipment, Systems Start-up
• Equipment design, qualification, and process validation.
• Manufacturing Execution Systems and electronic batch release.
• Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Continuous improvement methodologies and mindset – lean, six sigma, etc.
• Documentation, deviation and change management systems (e.g., Trackwise. Veeva QualityDocs, Kneat)

Additional Information

• Ability to wear safety equipment (glasses, shoes, gloves, etc.)
• Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.
• Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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