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Supervise daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), SOPs, environmental health and safety (EHS) guidelines and any other regulations that may apply. Monitor and insure efficiency and effectiveness in various areas and train employees. Perform all duties with a focus on optimizing safety, quality, service and cost.
Job Responsibility:
Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations
Supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
Identifies/prioritizes/provides resources as appropriate
Interviews, hires, coaches, motivates, develops, recognizes and manages performance of direct reports
Reviews, approves, and manages documentation for batch and system records
Assists in release of product for distribution and meeting product release time goals
Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens
Insures resources and raw materials are utilized in the most efficient and productive manner possible
Requirements:
Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
Ability to manage multiple priorities in a manufacturing plant setting
Strong professional writing skills and ability to prepare technical reports
Ability to understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry
Strong assessment and troubleshooting skills
Computer proficiency in Microsoft Office and ability to use enterprise software
Interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues
Work in and facilitate a team-oriented environment
Ability to collect and analyze data and information to determine paths for process improvement and potential root cause
Ability to respond to detailed inquiries, and present information to groups and senior management
General knowledge of manufacturing business acumen
May be required to supervise multiple groups
BS degree in a business, scientific, or engineering discipline with 1 year of manufacturing experience or high school diploma or equivalent with 3 years related manufacturing experience
Bachelor's degree required for ongoing career progression
Repetitive work for long periods, typically sitting
Very good manual dexterity is required
Ability to bend and to lift up to 35#
Must be able to work in a class 10,000 clean room following gowning and related guidelines
A variety of chemicals are used in the production areas routinely
Assembly and inspection of small components and materials with limited visual contrast requires vision to be correctable to 20/20
Ability to work closely with and provide work direction to others in a diverse culture and in high demand situations
Every employee is responsible for performing his/her job safely and for calling to management’s attention of unsafe conditions, practices, or equipment
May require overtime to meet production schedule
Ability at times to bend and stretch and to lift up to 35#
This job also involves hazardous materials and hazardous waste responsibilities which include understanding and complying with hazardous materials and hazardous waste regulations for job duties such as: proper handling, storage, hazardous waste in-house treatment using neutralization and dilution systems,and labeling requirements for hazardous materials and hazardous waste
Develops training content and facilitates and verifies appropriate training for employees in the area
Ensures compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required
Submits and/or maintains and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed
What we offer:
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave