Aseptic Cleaner - 2nd Shift

Department

Manufacturing

Job Title

Aseptic Cleaner

FLSA Status

Non-Exempt

1. Role Purpose:

The Aseptic cleaner 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.

2. Key Duties & 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.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

N/A

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• 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

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

.

b. Work environment:

N/A

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Evening shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Langhorne, PA 19047: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location