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SUMMARY DESCRIPTION
The Supervisor, Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday through Sunday) first shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements. This job is expected to work onsite. This is a weekend-12 hours first shift from Friday through Sunday.
SUPERVISION RECEIVED
Under direct supervision of the Senior Manager, Manufacturing.
SUPERVISION EXERCISED
Directly supervises weekend first shift manufacturing cleanroom operators and lead operators.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Ensures thorough behavior and action a safe working environment for all employees.
Facilitates teamwork and cooperation with a focus on developing a Lean culture, with the ultimate goal of a high level of employee engagement and customer satisfaction.
Ensures all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards.
Responsible for the overall direction, coordination, and evaluation of the manufacturing area, overseeing all production activities to ensure that all Standard Operating Procedures (SOPs) are properly followed.
Provides daily coaching and development to their direct reports.
Reviews production and operating reports and participates in the resolution of operational, manufacturing, and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards.
Trains and ensures all assigned employees are aware of and comply with company, government procedures, and regulations.
Partners with other functions such as Facilities, Maintenance, Engineering, Quality, Warehouse, and Planning groups to ensure a seamless flow of activities across and during the shift.
Participates in investigative teams to resolve ongoing issues including failure investigations. Perform investigations as they pertain to the manufacturing realm of responsibilities.
Reports any non-conformances in a timely manner.
Works closely with the quality department to coordinate the generation, and processing of non-conformances (NC), Corrective Preventive Action Plans (CAPA), and audit observations in a timely manner.
Pass and maintain gowning qualification for ISO 5 and ISO 7 Clean rooms.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance and managing employee performance, addressing complaints, and resolving problems.
May also perform other related duties, responsibilities, and special projects as assigned.
DESIRED MINIMUM QUALIFICATIONS
Bachelor’s degree or higher in Science, Engineering, or related fields is desired.
3+ years of relevant leadership experience in a GMP regulated industry.
Knowledge of NCs and CAPAs.
Must have strong written and verbal communication skills. Must possess strong leadership skills with team-focused attitude and approach.
Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.
Batch manufacturing experience.
Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
Strong computer skills, including Microsoft Office experience required.
Knowledge of Oracle R12/Agile preferred.
Understanding of Lean/six Sigma a plus.
TOOLS AND EQUIPMENT USED
General office equipment including but not limited to computer, telephone, and copier.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required for this position. In order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to periodically lift 25 lbs. The employee may be required to stand for prolonged periods of time.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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