Manufacturing Line Leader

Job Title: Manufacturing Line Lead
FLSA Classification: Full-Time, Non-Exempt/Hourly Professional
Work Location: Fall River, MA
Work Hours: Second Shift: 3:00 PM a" 11:30 PM, (May very based on business needs)
Reports To: Manufacturing Supervisor
Salary Range: $21.32 - $30.68/hr

The purpose of this role is to assist in manufacturing metered dose inhalation (MDI) products in a pharmaceutical manufacturing company.

The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.

This job is a multifunctional role. The primary nature of this job is to serve as a Manufacturing Lead. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Warehouse Operations, Packaging Operations, and Facilities Operations.

The Manufacturing lead performs all functions relating to the production of MDI (Metered dose inhalation) products; consistent with established Current Good Manufacturing Practices (cGMP), good documents procedure (GDP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Incumbents in this position are responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

• A manufacturing team leader is an expert in manufacturing activities such as processing and packaging of materials for production.
• Every manufacturing project requires the supervision of a skilled and experienced person to guide the team in ensuring production efficiency and quality; and that is where the manufacturing team leader comes in.
• The Lead exhibits great leadership skills by showcasing knowledge and skills to the team members, giving them directions to go about their tasks and duties on the job.
• The Lead motivates members of the team to harness their potential and work harder for the execution of projects.
• The Lead assigns tasks to team members and gives them specific directions and procedures to follow in carrying out assigned tasks.
• The Lead monitors team members in the course of their work and ensure that they comply with the standards of operations obtainable in the establishment.
• The Lead is responsible for providing leadership with the coordination of their direct supervisor for the team involved in a manufacturing environment. This means that they are directly engaged in active feedback and providing directions on improving execution of work projects.
• The lead sometimes takes the wheel and shows his/her team members practical ways to execute difficult tasks.
• The Lead gives the team members a clear direction of how to tackle such tasks on their own in the future.
• The Lead recognizes the contributions of every team member and encourages them to work together in harmony, sharing ideas and maintaining good work relationships in the execution of production tasks.
• The Lead places the safety of the team members in high esteem and educates them on safety tips and procedures to adhere to during the manufacturing process.
• The Lead carry out incident, accident and non-conformity investigations and associated reporting and action closure
• Consistently promote high standards through personal example and roll out through the team so that each member of the team understands the standards and behaviors expected of them
• The Lead teaches employees on best practices in handling emergencies that may arise in the course of work and ensures that the manufacturing site is free of any form of danger and is safe for team members to do their job. As part of safety measures, the leader also ensures that all workers have protective gear and clothing before going to site to work to safeguard themselves against production hazards.

• Dispensing raw material and primary packing material as per work order and checking of raw material and primary packing materials.
• Ensure the proper planning and execution of batches.
• Performing and checking of cleaning and sanitation of production area and machinery as per respective SOP.
• Daily monitoring of production.
• Performing and checking manufacturing process and documentation in batch record and logbooks.
• Ensuring machine operations with minimum rejections and maximum outputs while maintaining quality standards within the standard norms.
• Checking equipment and performing necessary maintenance on machinery.
• Safeguard equipment for smooth functioning with co-ordination of engineering for preventive maintenance and calibration.
• Maintaining inventory of machine parts, tools and accessories.
• Working individually and in collaboration with others as part of a team.
• Coordinating with other departments like packaging, engineering, QA and QC for better planning and execution.
• Check and ensure status labelling at all stages of manufacturing, filling and cleaning.
• Identifying and assisting in any corrective actions.
• Perform, check and ensure calibration/verification of instruments, equipment and weighing balances as per schedule.
• Perform line clearance activities.
• On-line documentation and timely entries related to manufacturing and filling operations and activities.
• Wearing appropriate PPE as stated in the SOP before entering any processing areas.
• Executing procedures to complete tasks in a safe and efficient manner.
• Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Performing other related duties assigned.
• Be able to operate a computer with ease.
• Knowledge of pharmaceutical manufacturing and related documents.
• Monitor workers on site during production activities to ensure adherence to ethics and safety procedures
• Knowledge of SAP system, master control and TrackWise system.
• Basic understanding of deviation, CAPA, change control, FMECA, OOS, OOT and OOAC.

a Maintaining and followed 100% cGMP, GDP and SOP Compliance during complete operation hours.
a Complying with all company policies and procedures.
a Reporting all issues that arises to the department head or reporting manager.
a Performing daily maintenance on equipment and machinery.
a Completing all documentation in a timely manner, ensuring their integrity, accuracy and completeness.
a Maintaining discipline in department.
a May be required to assist in the training of other employees in the department.
a Flexible to work extended hours, to achieve manufacturing schedule when needed.

All employees must undergo various training activities at the start of their employment. New trainings and re-trainings will occur periodically. Operators may be required cross-train in all areas of the manufacturing operations. Employees must strictly adhere to all safety, health, and environmental guidelines at all times and ensure that all safety precaution are being taken during handling of machines.
a

a High school diploma or equivalent is required.
a Accredited college certificate or university degree is preferred.
a Minimum one (1) year of manufacturing experience in the pharmaceutical industry. MDI or aerosol products experience is highly preferred.
a Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
a Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred.
a Basic understanding of mechanical machinery and the operating principles of control systems.
a Ability to follow both verbal and written instructions.
a Demonstrated ability to work in both independent and team environments.
a Good knowledge of Health & Safety procedures, including OSHA.
a Strong mathematical and organizational skills.

a This position requires the ability to do heavy lifting / bending frequently.
a Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
a Ability to wear appropriate PPE is required.
a Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in Indiaas pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of ther emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Ciplaas focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Cipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.