Aseptic Operator

Onsite Personnel LLC

Newtown, PA

Full-Time

Job Description

Summary: Aseptic Operator

The Aseptic Operator will be working in the production department along- side operations. The aseptic-tasks include cleaning and sterilization of processing equipment, parts, rooms and corridors. The Assistant maintains batch record documentation and logs as required by corporation and regulatory agencies. This role prepares, according to procedures, various stock solutions and buffers as required by the production process. In addition, this position is responsible for operating general production equipment.

Responsibilities:

Perform sanitization duties in the cleanroom while aseptically gowned.
Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit.
Accurately record and complete documentation as required. Including logbooks and forms in compliance with SOP guidelines
Administrative tasks including attendance of regularly scheduled departmental meetings and group trainings.
Will help with internal investigations (Deviations, Internal Audits, Safety Audits).
Maintain facility and equipment through routine cleaning and sanitization in designated areas within the standard operating procedures.
Operate general production equipment
Stocks cleaning supplies as necessary.
Maintains accurate and complete records.
Attends all training programs as required by Company SOPs, procedures and policies.
Reliable and regular attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Technical Proficiencies:

Capable of learning accurate cleanroom behavior and aseptic technique concepts.
Proficient in accurately recording and completing documentation as required, including logbooks and forms in compliance with SOP guidelines.
Comprehension of, Master Control referred.
Familiarity with basic Microsoft Office programs such as Word, Excel, and Outlook are preferred
Ability to work independently, within prescribed guidelines, or as a team member.
Detail Oriented.
Aseptic gowning, cleanroom, and/or cGMP experience preferred or the ability to receive Aseptic Gowning Qualification will be required