1+ months

Senior Aseptic Controls Manufacturing Supervisor

Eatontown, NJ 07799
Senior Aseptic Controls Manufacturing Supervisor


Eatontown, New Jersey, United States

Requisition #:


Post Date:

Dec 03, 2019

**Senior Aseptic Control Supervisor**

**RTG (Restorative Therapies Group) OVERVIEW**

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient **outcomes.**

**SPECIALTY THERAPIES** offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

Careers that Change Lives | Impact patient outcomes. Come for a job, stay for a career.

The Senior Aseptic Control Supervisor will organize, direct and control daily activities of the Aseptic Controls team and Assembly support function. Develop and maintain cleaning/sanitization processes for cleanroom areas and controlled environments. Ensure timely and accurate staging and sterilization of supplies/equipment. Provide necessary leadership to measure and monitor activities required to support daily production schedule, minimize non value-added activities, reduce cycle time and drive cost efficiencies. Select and develop personnel that meet expectations and support efficient operation of the Production function. Develop schedules and labor requirements for assigned areas. Responsible for ensuring compliance with Quality Systems, EHS, and other regulatory requirements. Must lead by example with integrity and a patient first attitude while focusing on continuous improvement and delivering high quality service.

**A Day in the Life**

Responsible for Aseptic Controls and Assembly functions required to support manufacturing operations in an ISO 5 environment

Serve as Management support for all Aseptic Controls and Assembly employees with minimal need for senior management oversight.

Champion the overall cleaning process to assure integrity of sanitization, cleaning and sampling practices

Maintain inventory of all cleanroom garments. Provide adequate stocking for all scrub room areas.

Responsible to support, plan and execute shutdown activities to ensure facility is brought up on time without sanitization positives and stocked with supplies and equipment to ensure on time production start.

Oversee ordering, receiving, storing, cleaning, sterilizing, issuing and usage for equipment and supplies used in Manufacturing.

Monitor the quality, efficiency, and effectiveness of departmental performance and associated metrics.

Identify and implement effective cost reduction initiatives.

Responsible for ensuring appropriate documentation and records in accordance with cGMPs.

Interfaces with Micro and Quality Assurance on environmental issues, investigations audits.

Responsible for responding to Facility interruptions in a quick, efficient and compliant manner.

Recommend the hiring termination of hourly employees as necessary.

Identify opportunities to develop personnel including: seminars, job rotation and cross-training.

Ensure team members have clear goals and performance expectations. Provide ongoing coaching and feedback consistent with employee needs. Conduct performance appraisals in a timely manner.

Act as coach and mentor for team members to achieve professional growth and greater job satisfaction.

Continually improves functions to reduce non value-added activities, cost, cycle time and outages while improving quality of service for processing.

Ensure compliance with all Federal, State and Regulatory laws, i.e. Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), American Association of Tissue Banks (AATB), etc.

Behave ethically in all situations and reports or challenges unethical behavior of others.

Should possess strong organizational, project management, and influencing skills with the ability to work on multiple projects and lead multiple teams.

Should be able to set priorities and meet deadlines in a fast-paced environment. Demonstrated ability to deliver projects on time and within budget

**SHIFT-4 daysM-TH; 10hr shift**

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience

**Nice to Have**

4+ experience in cleanroom/manufacturing environment with a biologics, pharmaceutical or medical device company preferred.

Understanding and working knowledge of principles regarding aseptic processing techniques and universal precautions.

Knowledge of Federal Drug Association (FDA)/Current Good manufacturing Practices (cGMP) device and/or pharmaceutical regulations.

Knowledge of Current Good Manufacturing Practices (cGMPs) and the American Association of Tissue Banks (AATB) requirements.

Must have a proven ability to drive adherence to production schedule

High-energy individual with strong work ethic, able to work in a fast paced environment.

Experience driving high levels of compliance with regulatory and quality systems requirements.

Excellent verbal and written communication skills including the ability to develop and present reports - ability to read, write, and understand the English language

Solid problem solving, effective decision making, and deductive reasoning skills

Ability to handle multiple assignments and responsibilities simultaneously

Ability to lead and work within a team to meet team goals/objectives - able to get results through others - able to effectively motivate subordinates to strive for high levels of achievement

Competent skills in using most common office software application

Skillful in formulating strategies, tactics and action plans to achieve results - ability to conceive creative solutions to complex problems

Ability to effectively influence key decision makers

Ability to work well under pressure and maintain positive, enthusiastic attitude

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2019-12-05 Expires: 2020-02-15

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Senior Aseptic Controls Manufacturing Supervisor

Eatontown, NJ 07799

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