Manufacturing Supervisor - Metered-Dose Inhaler

Manufacturing Supervisor | Metered-Dose Inhaler

Onsite in Fall River, MA

Full-Time

The Production Supervisor ensures compliance with cGMP's, company's policies, standard operating procedures, and FDA requirements. The incumbent will serve as a key resource for conducting product complaints, supports packaging, packaging components within approved procedures and regulatory requirements. This position reports to the Site Lead/Operations Manager.

• Schedule the production process, including setting specific targets for phases of production.
• Delegate responsibilities for production to team members and creating team leadership positions to oversee groups of employees.
• Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements.
• Conduct performance assessments and compiling reports on the production process to identify areas where efficiency can be increased.
• Perform raw material and component review to ensure correct quantities, labeling and visual appearance.
• Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging.
• Follow Master Batch Records for the packaging of MDIs dosage forms when required.
• Identify defects and report quality issues.
• Set up, operate, and clean in compliance with batch records and SOPs, packaging equipment.
• Clean and sanitize packaging equipment per SOPs.
• Complete accurate and timely documentation. Follow good documentation practices in accordance with cGMP.
• Perform in-process testing and inspections as required by Master Batch Record (weighing, visual inspection etc.).
• Effectively performs activities and applies knowledge in accordance with approved SOPs, company policies, regulatory requirements, schedules and provides technical expertise and direction to colleagues.
• Actively participate in Production team and Site communication meetings.
• Support GMP investigations and events.
• Contribute to Standard Operating Procedure (SOP) writing in technical area.
• Understand and operates all necessary equipment and instrumentation to perform activities.
• Maintains documentation in accordance with internal procedures and regulatory requirements (i.e., GMP, SOPs etc.).
• Interfaces with appropriate Warehousing, Planning, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.
• Performs activities for manufacturing (i.e., batch record review, packaging line clearances and manufacturing room clearances, deviations, etc.).
• Comprehend and adhere to all pertinent EHS regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
• Responsible for compliance with documentation and accountability procedures and policies, maintaining high alert to diversions.
• Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; recognize safety and health related issues and report to management.
• Independently searches, gathers, and presents information to support compliance with regulations and internal systems.
• Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
• Perform other duties as assigned.

• Bachelor's degree in pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required.
• Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.

• Understanding of machines used in pharmaceutical manufacturing.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• 3+ years' experience in a pharmaceutical setting preferred.
• General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Packaging with serialization preferred.

• Proficiently speak English as a first or second language.
• Ability to read, write and communicate effectively.
• Ability to understand and analyze…