Operator I

Description:

Title: Operator I

No. of positions: 2

Shift Schedule: Monday-Friday, 2:00 PM to 10:30 PM (Two 30-minute lunch breaks each)

Duration: 6 months with possible extension

Temp to perm: Yes, depending on openings and performance

Core Essential Skills:

1) Prior Pharmaceutical background and manufacturing experience.

2) Experience with blending materials and working with granulations.

3) Stable employment history/longevity, 1+ year in their most recent position(s)

4) Reliable attendance and dependability

5) Strong work ethic and eagerness to learn

6) Ability to perform the various processes within the department following training

7) English proficiency - reading, writing, and communication

8) Willingness and ability to work overtime as needed, understanding that overtime may vary from week to week

9) Comfortable climbing ladders up to 15ft and rolling pallets up to 75 pounds using lifters

Screenings:

1. Basic BKG

2. 11 Panel Drug + Fentanyl

3. Medical Screenings

A) Vision Screen - Near, Far, Color, Depth and Peripheral

B) Vital Signs

C) Urine Dip Analysis

D) Whisper Test

E) Audiogram & Noise and Hearing Questionnaire (remove for office or lab personnel)

F) Spirometry & OSHA Respirator Questionnaire (remove for office or lab personnel)

G) Lifting Assessment 30 pounds

Essential Duties & Responsibilities:

This role will require workers to climb ladders using a lift or a ladder up to 15 ft for cleaning and some setup procedures. This would occur 2-3 times per week.

• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Reports process or equipment problems to supervisor; performs minor or basic troubleshooting.
• Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
• Maintains records of manufacturing process by recording data on batch record.
• Sets-up and operates equipment for processing operations.
• Communicates effectively with previous and incoming shift operator and related personnel.
• Cleans and maintains processing rooms and equipment.
• Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
• Monitors product quality.
• Performs reconciliations.
• Conducts in-process testing.
• Checks and adjusts calculations.
• Checks/reviews labels and batch records for accuracy.
• Suggests improvements in methodology or process.
• Understands concept of delivery/on-time production.
• Follows established department SOP's and batch record instructions.
• Complies with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.

Position Requirements:

Education Required/Preferred: High School Diploma or equivalent.

Experience Required: Prefer 0-1 year of work experience in a Manufacturing environment.

Physical Requirements: Incumbents in this class are subject to regular and/or routine periods of sitting, standing, walking, stooping, reaching, and climbing, visual acuity to monitor and/or read, communicating orally with Company management, peers and co-workers, and occasional periods of moving and lifting a minimum of 35 pounds. Work is performed in a manufacturing environment with noise levels varying from moderate to loud depending upon machinery usage. Work performed may require the use of a respirator and incumbents may be subject to a Pulmonary Function Test (PFT) to determine eligibility for fit-testing.

Specialized or Technical Knowledge Licenses, Certifications needed: N/A

Job-specific Competencies:

1. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

2. Proper English grammar and punctuation.

Effective oral and written communication skills.

3. Basic math skills.

4. Complying with all Company safety rules and regulations.

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