Bioprocess Associate - 1st Shift at Bora Pharmaceuticals

Camden, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 26

Salary

70615.0

Posted On

03 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Regulations, Aseptic Operations, Equipment Troubleshooting, Documentation Practices, Training, Sanitization, Manufacturing, Housekeeping, Teamwork, Independence, Data Statistical Software, Word Processing, Spreadsheet Software, Presentation Software, Plant Upkeep

Industry

Pharmaceutical Manufacturing

Description

I. JOB SUMMARY Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Perform 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. This position is for our 1st shift, working 6:00 AM - 2:30 PM, Monday - Friday. However, hours may change based on business or organizational needs. II. 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. • 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 sterile 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 sterile equipment as necessary for routine aseptic operations • 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. 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 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. IV. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.

Responsibilities

The Bioprocess Associate is responsible for the filling of parenteral pharmaceuticals and the setup and operation of equipment associated with sterile filling processes. Daily cleaning and sanitization activities throughout the production area are also key responsibilities.