I. JOB SUMMARYThe Production Supervisor will be responsible for execution of preparation of activities associated with 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.
II. ESSENTIAL FUNCTIONSReasonable 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 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.
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 3 years' experience in cGMP or regulated environment.
- Or High School/AA with a minimum of 8 years' experience in cGMP environment.
- 3 years previous supervisory experience in cGMP environment preferred.
SKILLS
- 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.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICSThe physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Compensation Range:$75,789.00 - $113,684.00Bora 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