Careers Tyber Medical is always looking for talented people to join our team. If you are interested in our careers, you can email us your resume to keep on file at Careers@tybermed.com Title: Supervisor, Production Operations (Sterile Inspection/Pkg) Main function: Supervises work teams and provides leadership to production supervisors in the manufacturing, filling and/or packaging of high-quality medical device products according to schedule, cost, and quality standards while maintaining human relations, safety performance, and ensuring adherence to all regulatory control and documentation procedures. Handles Production/Engineering related projects to increase production efficiencies and add flexibility to adopt new contract work. This function is performed in an ISO 8/7 clean room; adherence to established environmental requirements is essential. Principle Duties / Responsibilities Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Ensures that established standards, including production, quantity and quality are met. Takes direct action to correct deviations and report variances and exceptions to the assigned position supervisor and follow up on corrective action. Ensures that all production operations are validated and fully comply with all Current Good Manufacturing Practices (cGMPs). Responsible for area compliance for the FDA, QAT, and OSHA inspections. Uses available resources effectively; plans, monitors, meets, and (if required) revise daily production schedules as measured by comparison of actual production with scheduled production to produce a quality product in an efficient manner. Administers department safety programs so that operative personnel understand and complies with safety rules and procedures. Works in a safe manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements Evaluates performance and skills of personnel and communicates same so that performance is continually improved and skills are progressively developed. Takes corrective action including discipline when required. Performs annual employee evaluations. Assists technical staff and customers in technical issues to ensure new transferred processes are robust and validated. Approves process validation protocols. Establishes and approves the technical requirement for production documentation including equipment and systems specifications, manufacturing formulas, POMS procedures, filling and packaging work orders, Standard Operating Procedures (SOPs), Environmental Procedures, PMs, etc. Implements cost reduction programs in order to stay competitive in the present economy. Tracks employees’ attendance, approval of time cards, trainings, etc. Perform other duties as assigned. Perform Preventative Maintenance Activities Required Knowledge, Skills, and Abilities Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities. Ability to stand for extended periods of time (up to 8 hours or more). Proficient in Microsoft Office (Excel, Word, Outlook). Excellent verbal and written communication skills. Ability to adhere to written production records and validation protocols. Strong understanding of basic math and writing skills to document production activities in batch records and/or log books. Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements. Capability to operate on a fast-paced manual assembly line using basic production equipment. Ability to legibly complete required documentation. Technical ability to assemble and disassemble packaging equipment. Strong analytical and problem-solving skills. Supports management’s decisions and communicates change positively Maintains open and constructive dialogue with other leaders Take ownership for their responsibilities and their team’s performance Creates a cadence of accountability for their team Ability to analyze and make decisions within time and schedule constraints Proactively and effectively manages performance Ability to quickly make decisions and understand the impact on processes and employees. Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Competencies/Candidate Profile Technical and operational knowledge of aseptic processing operations, ability to handle multiple ongoing activities, and ability to prioritize tasks. Position is the key interaction with customers in commercial operation of the described lines. Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Required/Preferred Education and Licenses High school diploma, GED or equivalent required. Bachelor’s degree in scientific discipline or related field or equivalent experience preferred. 3 or more years of experience in a GMP manufacturing environment. Specific training in cGMP is desired Acceptable results on basic skill assessment. Working Conditions Shift work in a manufacturing environment May require overtime.