Job Description

POSITION SUMMARY

The processing assistant is an integral part of the overall process required to convert raw material to finished products. This position is responsible for the set-up, operation and cleaning of various types of process equipment and tool utilized to pool, separate, filter, fill, inspect and package the finished product.

ESSENTIAL DUTIES & RESPONSIBILITIES may include the following. Other duties may be assigned.

· Responsible for preparation and assisting the operation in an aseptic biologics processing following established Standard Operating Procedures (SOPs), Master Batch Records and Good Manufacturing Practices (GMPs). Processing work is performed in a ISO 7 clean environment.

· Operates manufacturing equipment such as centrifuges, biosafety cabinet, incubator and -20 freezers, steam autoclave and oven.

· Responsible for facility and equipment cleaning and for tools cleaning and autoclave.

· Responsible for receiving human blood-derived component units and moving units to freezer to ensure material quality.

· Ensures plasma blood-derived component and products are properly stored according to SOPs, which could include unsuitable units and samples.

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

· High school diploma or GED required. Associate’s degree, applicable certification.

· Must have bio-aseptic knowledge and experiences.

· Must be proactive, results oriented, and have strong attention to detail.

· Self-starter with strong work ethic and the ability to exercise good judgment.

· Strict adherence to procedures and practices according to corporate SOP.

· Strong emphasis on documentation according to corporate SOP.

· Adhere to departmental corporate safety policies.

· Must be able to read, write, and speak English.

· Computer literacy with proficiency in MS Office (Outlook, Word, Excel).

· Flexible with working hours / shifts in order to accommodate the 7day plant operation.

· Will expose to dry-ice and biological hazards.

PHYSICAL REQUIREMENTS

· Ability to lift /move up to 40 pounds.

· Ability to gown and work in an aseptic/clean room environment.

· Ability to work in a cleanroom for extended periods - up to five (5) hours at a time.

· Manual dexterity to perform all job functions.

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