Manufacturing Supervisor | Metered-Dose Inhaler

Manufacturing Supervisor | Metered-Dose Inhaler

Onsite in Fall River, MA

Full-Time

The Manufacturing 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.

Responsibilities

• 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.

Education and Experience

• Bachelor's degree in pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required.
• Pharmaceutical industry experience.
• 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.

Technical Knowledge and Computer Systems Skills

• 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.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language.
• Ability to read, write and communicate effectively.
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• A strong understanding of work discipline, Chain of Command and Teamwork
• Able to apply knowledge and experience to complex problems and offer recommendations.
• High standards in Safety, Environmental, and Leadership
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Basic computer skills (Word and Excel) – Intermediate
• Good basic math knowledge and excellent attention to details.

Work Schedule and Other Position Information :

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.