Supervisor Production

Bora Pharmaceuticals•Baltimore, MD

42d•$84,000 - $126,000•Onsite

About The Position

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.

Requirements

BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
Or High School/AA with a minimum of 8 years' experience in cGMP environment.
Good written and oral communication skills.
The ability to lead a group including motivating and inspiring the team.
Strong problem-solving skills as well as the ability to provide and accept feedback.
The ability to identify and resolve issues in a timely manner.
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 handle multiple tasks and projects at the same time, and good time management.

Nice To Haves

3 years previous supervisory experience in cGMP environment preferred.

Responsibilities

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 equipment preparation 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.
Basic understanding and operation of vial washers, autoclaves, and depyrogenation ovens; basic understanding of manual cleaning of equipment in a pharmaceutical environment
Author & Implement CAPAs, Deviations, and Change Controls