Production Super

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Ensures all work is done safely and in compliance with all EHS, DEA, & cGMP guidelines. Directs production supervisors in the day-to-day operations of the Manufacturing and Packaging departments with the approval of the Focus Factory Managers as well as be a point of contact for support groups. Reviews and adjusts production schedules as needed; Directs production supervisors in setting scheduling priorities. Responds to difficulties affecting the production schedule. Order and implement change as needed. Use appropriate escalation to Focus Factory Manager and Operations Manager as necessary. Reviews and analyzes information using various tools such as lean sigma, 6S, Root Cause Analysis Tools, etc. Prepare and implement action plans based on these analyses. Establishes plans around continuous improvement activities and providing the information to the Focus Factories. Acts as the primary liaison for the department to other functional areas within the facility including, but not limited to, Quality Control/Assurance, Compression, Packaging, Regulatory Affairs and Human Resources. Oversees the procurement of raw materials and other production components. Oversees and participates in as needed the development of Standard Operating Procedures, Current Good Manufacturing Practices, installation qualifications, operational qualifications, training manuals and department communication. Participates in and interacts with other production and plant supervision in regular meetings related to employee issues, operational issues, etc. Deliver training formally and informally to personnel within the listed departments. Assists specifically and actively in the training and development of all exempt and nonexempt employees. Functions alongside Human Resources as a mediator and problem-solver for personnel issues arising within the shift's Manufacturing, Packaging, and support departments. Counsel personnel as necessary as outlined in company policy. Assists production supervisors in developing and delivering disciplinary actions for employees. Audits and provides guidance on the various production processes of the listed departments such as batch records, attendance records, production reports, accident reports, incident reports, etc. Performs all work in a safe manner. Support the safety initiatives of the facility and communicate this support to all Manufacturing, Packaging and support departments. Assists and participates in the on-boarding process new hires

inimum Requirements

Education

• Four year degree required, preferably in a technical field OR

Experience:

• Five or more years of experience in the pharmaceutical industry in finished dosage manufacturing and packaging or related field to gain sufficient skill to perform the essential functions of the position within safety, compliance and attainment standards

Preferred Skills/Qualifications: .

• Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format
• Knowledge of FDA and DEA regulations
• Knowledge of Quality Systems
• Knowledge of cGMPs for Finished Dosage Products
• Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience
• Ability to quickly identify, communicate and/or resolve issues

Other Skills/Competencies:

• Strong working knowledge of Microsoft Office products including Word and Excel

Shift: This position will be required to work on 2ND Shift (4pm-2:15am. Monday -Thursday, Friday will be for OT support if needed).

This position reports to the Senior Operations Manager and has a dotted line report to the Packaging and Manufacturing Focus Factory Managers, Maintenance Manager, and Warehouse/Distribution Managers. This role will have an ad hoc responsibility for providing support regarding performance reviews.

Organizational Relationship/Scope:

ORGANIZATIONAL RELATIONSHIPS/SCOPE. Operations Superintendent supports the pharmaceutical manufacturing and packaging process and may be assigned within specific focus factory or in a general plant support role. Position interacts with production technicians, production supervisors, production managers, project managers and Leadership team members.

Drive for Results Sets and maintains high performance standards for self and others that support the organization's strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.

Problem Solving Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers for true root cause determination.

Timely Decision Making Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.

Written Communications Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.

Process Management Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.

Time Management Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.

Incorporates Mallinckrodt Core Values in daily routine:

Patient-Centric: Our decisions and actions are guided by our commitment to improve lives.

Collaborative: We are inclusive and work together towards our common goals.

Innovative: We are agile, always seeking new ways to continuously improve our performance.

Integrity: We do what we say we are going to do.

Working Conditions:

Works an equal amount of time on the production floor in a manufacturing facility and an office type environment. The time spent on the production floor may be extended periods of time within a manufacturing facility.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required