Supervisor, Production - 2nd Shift - Baltimore

Job Summary

The Production Supervisor will be responsible for execution of production fill activities associated with a RABS (Restricted Access Barriers System) fill line, including development of procedures and subsequent training of operators, supporting execution of qualification activities, and ensuring compliance with safety standards and established policies and procedures. This role requires the following skills: good written and oral communication skills, the ability to lead a group, leadership through inspiring and motivating the team, the ability to provide and accept feedback, strong problem solving skills, the ability to identify and resolve issues in a timely manner, a willingness to make decisions and apply proper judgment based on sound, accurate information, flexibility and the ability to maintain effectiveness when experiencing major changes in work schedule and priorities, the ability to handling multiple tasks and projects at the same time, and good time management.

This position will support the 2nd shift Operations working -2pm-10:30pm Monday -Friday.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Monitor and ensure compliance by all personnel with cGMP regulations, Company policies, and SOP and Batch Record directions. Maintain a high degree of visibility and access to employees throughout the shift.
• Responsible for development of procedures and batch records associated with filling operations and subsequent training of operators.
• Provide technical expertise and support for execution of qualification activities.
• Review documentation, including executed batch records, and ensure that it complies with Good Documentation Practices.
• Coordinate, schedule, and oversee Equipment Preparation activities.
• Interface with the Quality Assurance; Facilities and Maintenance; Materials Management; and Manufacturing, Science, and Technology departments to resolve production, supply, and equipment issues. Document issues through deviations and assist with investigations, as necessary.
• Extensive understanding and operation of vial and syringe fill machines, capping operations, Terminal Sterilization and Lyophilization; Extensive understanding of manual cleaning of rooms in a pharmaceutical environment
  
  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Iii. Minimum Education, Experience, Skills

• BA/BS in science or technical field with minimum of 5 years’ experience in cGMP or regulated environment.
• Or High School/AA with a minimum of 10 years’ experience in cGMP environment.
• 3 years previous supervisory experience in cGMP environment preferred.
• RABs/Isolator technology experience preferred
• Aseptic Drug Product Manufacturing experience preferred
  
  

Compensation Range

$75,789.00 - $113,684.00

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category