What are the responsibilities and job description for the Team Lead, Production-3rd Shift position at Bora Pharmaceuticals?
JOB SUMMARY
Reports to Shift Supervisor and leads a team that is tasked with preparation and filling of parenteral pharmaceuticals in accordance with cGMP regulations. Responsible for ensuring setup and operation of equipment and processes associated with sterile filling processes. Responsible for execution of daily cleaning and sanitization activities throughout the production area as well as ensuring operations are documented in accordance with cGMP regulations.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lead all on-floor daily activities as per the production schedule
- Extensive hands-on knowledge of Aseptic filling operations and understanding of first air concepts
- Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), current Good Manufacturing
- Execute daily tasks such as washing / sterilizing vials and filling components for use in production operations.
- Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre / postproduction
- Foster team building and provide the necessary training to other staff members as required.
- Recommend revision to batch records and SOPs; suggest regular process improvements
- Perform routine reviews on executed batch records and logbooks.
- Lead implementation of corrective actions and changes
- Generates Purchase requisitions and service receipts for consumables items within the MFG department.
- Perform tasks under minimal supervision, and in a compliant manner to meet production schedule.
- Inform manager on progress of projects, transfer of data, process details, etc.
- Communicate and suggest regular process improvement to management.
- Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
- Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
- Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations.
- Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required.
- As necessary, prepare, clean, or sterilize equipment as necessary for routine aseptic operations
- Restricted Access Barrier System (RABS) : Maintain proper gowning qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5 / 6 areas, and loading / unloading Terminal Sterilization autoclaves and Lyophilizers.
- Isolator : Maintain proper gowning qualifications; Demonstrate aseptic technique and able to conduct cleaning activities in a clean room environment.
- May be called upon to assist in general production activities when necessary.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Preferred :
PHYSICAL / MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The 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.
Compensation Range :
68,891.00 - $103,337.00
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
Salary : $68,891 - $103,337
