BioProcess Associate-3rd Shift

Job Description

JOB SUMMARY

Perform preparation and filling of parenteral pharmaceuticals in accordance with cGMP regulations. Responsible for setup and operation of equipment and processes associated with sterile filling processes. Responsible for daily cleaning and sanitization activities throughout the production area.

Essential Functions

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

• Work under general supervision of more experienced Technicians or Manufacturing Supervisors to produce parenteral drugs.
• Comply with cGMP regulations, adhere to established policies, SOP and Batch Record directions.
• Report any unexpected observations and suggest possible explanation and resolution.
• Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
• Independently set up, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the aseptic core, in accordance with current industry, client, and established standards.
• Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
• 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.
• 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.
  
  

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

• BA/BS in any field
• Or High School/AA with at least 3 years of experience in a GMP environment
• Ability to work independently with minimal guidance and as part of a team.
• Experience using computer applications, including data statistical, word processing, spreadsheet, and presentation software.
  
  

Preferred

• Experience in filling using Restricted Access Barrier (RABs) or Filling Isolator Technology
• Experience in preparation of material or equipment in a clean room environment
• Experience in operating Vial Washers, Sterilizing Autoclaves, or Sterilizing ovens
  
  

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

$47,077.00 - $70,615.00

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