I. JOB SUMMARY
The Bioprocess Associate position reports to Supervisor Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are preferred but not required. This role is responsible for filling of parenteral pharmaceuticals in accordance with cGMP regulations, setup and operation of equipment and processes associated with sterile filling processes, and daily cleaning and sanitization activities throughout the production area.
II. 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 Supervisor to produce parenteral drugs.
• Comply with cGMP regulations, adhere to our client’s policies, and adhere to our client’s SOP and Batch Record directions.
• Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed including recording entries in batch records or equipment logbooks.
• Train in setup, assembly, and operation all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core or sterile isolator, in accordance with current industry, client and standards.
• Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
• Perform housekeeping, plant upkeep, and sanitization activities throughout production area as required.
• Obtain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations and cleaning.
• Assist with the preparation of materials needed for sterile filling.
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 one year experience in a GMP environment
• Ability to work independently with minimal guidance and as part of a team