The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform manual inspection and train in the automatic inspection/packaging area for setup, of automated equipment and manual inspection processes, labeling and packaging equipment duties, line clearances and assist with inspection/packaging schedule. In conjunction with the Supervisor, the Technician plays a critical role in assuring safe, effective and compliant activities are performed in the manual inspection process while maintaining production schedules. The Equipment and Process Technician I will be proficient in all activities associated with the inspection process and be able to work with minimal supervision. The Technician will receive direction, training and mentorship from the Supervisor of Inspection and Packaging.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

* Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor.

* Maintains accurate and complete records.

* Maintains an accurate and complete Training Record.

* Ability to set-up Manual Inspection process with little to no assistance.

* Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities.

* Physically performs inspection reconciliation and provides documentation oversight and acknowledgement for such activities.

* Ability to review executed batch records and log books prior to submitting for final Production review.

* Provides accurate and complete assistance to Quality Assurance as needed.

* Works in a safe and effective manner.

* Identifies and reports unsafe and non-compliant conditions.

* Maintains work space in a clean and orderly manner.

* Perform any other tasks/duties as assigned by management.

* We all must embrace the QUALITY culture.

QUALIFICATIONS AND REQUIREMENTS

* High School diploma or GED preferred. Some college or technical training is a plus.

* Minimum 1-year work experience in inspection, packaging, quality control and/or production preferred.

* Must be able to work independently, completing assigned tasks with limited supervision.

* Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.

* Excellent organizational, interpersonal and communication skills (oral and written).

* Ability to take feedback constructively and consider the viewpoints of others.

* Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

* Ability to work overtime as needed.

PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS

* Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

* Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

* Employee must be able to occasionally lift and/or move up to 50 pounds.

* Must be able to sit for extended hours, focusing and concentrating on items being inspected.

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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