Packaging Operations Operator - Night Shift - Mon-Thurs (7pm-5am)

Lannett Company; Seymour (IN); On-site; USD 42,000 - 52,000; Full time

Job summary

The Lannett Company is seeking a Production Operator to perform all functions related to the processing of drug products in accordance with cGMP and SOPs. You will ensure safe, accurate execution of tasks and maintain compliance with quality standards during manufacturing and packaging of oral solid dose products.

You will work within the manufacturing and packaging departments, operating equipment, documenting batch records, performing in-process quality checks, and supporting continuous

Qualifications

• Knowledge of metric and English weighing and measurement systems.
• Basic understanding of mechanical machinery and control systems.
• Demonstrated mathematical ability in basic operations and percentages.
• Ability to use a calculator and computer systems (Word, Excel, SAP, Outlook, SharePoint, MasterControl, SuccessFactors).
• Ability to follow verbal and written instructions including SOPs and Batch Record documentation.
• Accurate and precise data recording and batch information.
• Proficient in reading and writing English.
• Demonstrated ability to operate pharmaceutical processing equipment and meet cGMP standards.
• Demonstrate understanding of unit operations and assist with on-the-job training of trainees and operators.
• Complete visual inspections and accountability.
• Exert physical effort including lifting up to 50 pounds with assistance.
• Must wear respiratory PPE as required.

Responsibilities

• Executes Batch Record and logbook documentation with detail and accuracy.
• Performs required in-process product quality checks and documents accurately.
• Executes procedures to complete tasks in a safe and efficient manner.
• Executes procedures to clean pharmaceutical production & packaging equipment and facilities.
• Operates pharmaceutical production & packaging machinery and executes steps such as dispensing, mixing, granulation, coating, encapsulation, milling, blending, compressing, printing, laser drill inspection.
• Execute in changeovers.
• Maintains production/packaging reporting for assigned work unit operation.
• Work in collaboration with others as part of a team.
• Assists with on-the-job training of other production trainees and operators.
• Effectively communicates issues to supervisor.
• Assists in identification and implementation of continuous improvement opportunities.
• Performs other related duties as assigned to meet departmental and Company objectives.

Skills

Measurement systems

Mechanical understanding

Math skills

Calculator & office apps

SOP & Batch records

Data recording

English literacy

cGMP compliance

Unit operations

Visual inspection

Physical strength

PPE proficiency

Tools

SAP

Outlook

SharePoint

MasterControl

SuccessFactors

Job description

Description

Summary

Performs all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conduction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

Scope of Job

The production operator is a position within the manufacturing & packaging departments that is solely responsible for the operations of equipment utilized in the production and packaging of oral solid dose products.

Documentation

• Executes Batch Record and logbook documentation with detail and accuracy
• Performs required in-process product quality checks and documents accurately
• Executes procedures to complete tasks in a safe and efficient manner.

Operations of Equipment

• Executes the procedures used to clean pharmaceutical production & packaging equipment and facilities
• Executes procedures to complete tasks in a safe and efficient manner.
• Operates pharmaceutical production & packaging machinery and executes procedures for manufacturing such as dispensing, mixing, granulation, coating, encapsulation, milling, blending, compressing, printing, laser drill inspection and the like.
• Execute in changeovers
• Maintains production/packaging reporting for assigned work unit operation.

Teamwork

• Work in collaboration with others as part of a team
• Assists with on the job training of other production trainees and operators
• Effectively communicates issues to supervisor
• Assists in identification and implementation of continuous improvement opportunities
• Performs other related duties as assigned to meet departmental and Company objectives

Requirements

Physical Requirements

• Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, pull, push, grasp, feel, talk and hear.
• Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
• Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point.
• Must have the ability to identify and distinguish colors.

Experience

• 0-2 years of Production/Packaging experience is an asset. Strong background in solid dose manufacturing or packaging preferred. Must be capable of working various hours/shifts and weekends when necessary.

Specific Skills

• Knowledge of the Metric and English weighing and measurement systems
• Basic understanding of mechanical machinery and the operating principles of control systems
• Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages
• Ability to use a calculator and computer systems (Word, Excel, SAP, Outlook, SharePoint, Master Control, Success Factors)
• Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation
• Accurate and precise in recording data and batch information
• Proficient in reading and writing English to understand work instructions and document results
• Demonstrated ability to operate pharmaceutical processing equipment and meet required standards of cGMP’s
• Demonstrate understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators
• Complete visual inspections and accountably
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Must be able to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.