Summary:

The main functions of the Sterile Filling Area are to set up and operate filling/sealing-automated equipment in a cleanroom environment. In addition, clean and sanitize the equipment and areas utilized for the filling/sealing operation. Operation occurs in a cleanroom environment and is governed by strict standards of sterility and regulatory agencies.

The operators in this area aseptically fill parenteral products in liquid and lyophilized (freeze-dried) form, seal the vials, and ensure that Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) are followed at all times.

Essential Duties and Responsibilities:

· Comprehend and follow SOPs, cGMPs, and good aseptic techniques to produce sterile quality products.

· Aseptically assemble and operate automated filling equipment & sealing equipment.

· Aseptic gowning for various classifications of cleanroom areas

· Documentation and review of associated paperwork for accuracy and clarity.

· Perform in-process inspection or pre-inspection of vials as necessary.

· Stock gowning materials for gowning.

· Perform cleaning and sanitization of work areas.

· Working with peers to help train each other as directed by Production Management.

· Other duties as assigned

Supervisory Responsibilities:

This job has no supervisory responsibilities.

Education and Experience:

High school diploma or general education degree (GED); 0-2 years related experience (production, manufacturing, and clean room experience preferred) and training; or equivalent combination of education and experience.

Language Skills:

Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations—the ability to write reports, business correspondence, and procedure manuals. Have the ability to effectively present information and respond to questions from managers, clients, customers, and the general public.

Mathematical Skills:

Add, subtract, multiply, and divide into all units of measure using whole numbers, common fractions, and decimals. Have the ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills:

Know Internet software, Manufacturing software, Spreadsheet software, and Word Processing software.

Other Skills and Abilities:

· Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products.

· Document information, events, and cGMP manufacturing processes, accurately and completely.

· Perform duties in an organized, detail-oriented manner.

· Apply basic math: measures, weights, fractions, and decimals. Apply basic computer skills.

· Work and communicate well with others in a team environment.

Other Qualifications:

· Pass Wonderlic Basic Skills Test at the 12th-grade level or higher. Must be able to obtain and maintain gowning certification. Must be able to wear a respirator

· Pass a background check, a drug screen, and a physical.

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee must stand for long periods of their shift; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift to 10 pounds, frequently lift and move up to 25 pounds and occasionally lift and move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

The work environment characteristics described here represent those an employee encounters while performing this job's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly exposed to toxic or caustic chemicals. The employee is frequently exposed to moving mechanical parts; fumes, or airborne particles; risk of electrical shock; explosives; risk of radiation and vibration. The employee is occasionally exposed to extreme cold, heat, and wet and humid conditions. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and perform any other job-related duties requested by anyone authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to accommodate individuals with disabilities reasonably. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

Job Type: Full-time

Pay: $20.00 - $21.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 12 hour shift
• Day shift
• Night shift

Education:

• High school or equivalent (Required)

Language:

• English (Required)

Shift availability:

• Day Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: In person