EW Finishing Operator at Alltech Consulting Services Inc
St. Petersburg, FL 33716
About the Job
Job Description:
To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment at Company. Create a workplace that is safe, clean, environmentally friendly, employee friendly, highly productive, efficient and of sufficient capacity to support the forecasted demand as predicted by Company Pharma Solutions.
II. Basic Function:
Under supervision, performs quality inspections to identify and remove sub-standard quality softgels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP). Programs and operates machines that clean and count capsules in the final stage of the production cycle. Packages capsules in cartons and loads sealed cartons for shipment staging.
III. Specific Activities, and Responsibilities:
• Accurately completes documentation related to the Finishing process.
• Inspects softgels to either approve or reject for quality. Performs re-inspection when necessary.
• Handles tray stacks and stages stacks for inspection or packaging.
• Inspects and cleans empty trays for use in the production cycle.
• Operates softgel washers and counting line machines, including scales. May be required to operate softgel printing machines.
• Performs line clearances between product lots.
• Packages softgels in bulk and properly identifies cartons of softgels with product labels.
• Transfers sealed cartons of softgels in box room or warehouse, when necessary.
• Performs work according to safety policies and practices related to the position.
• Handles non-hazardous, hazardous and DEA waste.
• Maintains a clean work area.
• Notifies Supervision immediately regarding potential quality issues which may require QA notification.
• Cross - training to perform tasks, operate equipment and maintain the necessary documentation in other production departments will be required.
• Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in an area different than her/his primary position/business unit.
• Update SOPs for assigned department as needed.
IV. Knowledge Requirements:
Education or Equivalent:
• High School diploma or equivalent required.
• Previous manufacturing experience and work in a GMP regulated industry preferred
Knowledge/Skills Requirements:
• Basic computer skills including Windows navigation and data entry.
• Must be able to read, write and communicate in English.
• Ability to read, interpret and execute written instructions.
• Ability to add, subtract, multiply, divide and combine units of measure. Ability to calculate fractions and decimals.
JD – Operator, Finishing – Revised February 2021
• Ability to solve practical problems.
• Ability to interpret and perform work against a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to multi-task and meet deadlines under pressure
Physical/Mental Requirements:
• Individual may be required to sit intermittently, stand regularly, walk regularly and consistently lift to 30 pounds; no lifting greater than 44.09 pounds without assistance, for a work period of up to 12-hours.
• Ability to push and/or pull on average 144 kg (approximately 460 pounds).
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Company’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Read written documents and frequent use of a computer monitor.
• In addition, will be required to operate industrial machinery.
To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment at Company. Create a workplace that is safe, clean, environmentally friendly, employee friendly, highly productive, efficient and of sufficient capacity to support the forecasted demand as predicted by Company Pharma Solutions.
II. Basic Function:
Under supervision, performs quality inspections to identify and remove sub-standard quality softgels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP). Programs and operates machines that clean and count capsules in the final stage of the production cycle. Packages capsules in cartons and loads sealed cartons for shipment staging.
III. Specific Activities, and Responsibilities:
• Accurately completes documentation related to the Finishing process.
• Inspects softgels to either approve or reject for quality. Performs re-inspection when necessary.
• Handles tray stacks and stages stacks for inspection or packaging.
• Inspects and cleans empty trays for use in the production cycle.
• Operates softgel washers and counting line machines, including scales. May be required to operate softgel printing machines.
• Performs line clearances between product lots.
• Packages softgels in bulk and properly identifies cartons of softgels with product labels.
• Transfers sealed cartons of softgels in box room or warehouse, when necessary.
• Performs work according to safety policies and practices related to the position.
• Handles non-hazardous, hazardous and DEA waste.
• Maintains a clean work area.
• Notifies Supervision immediately regarding potential quality issues which may require QA notification.
• Cross - training to perform tasks, operate equipment and maintain the necessary documentation in other production departments will be required.
• Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in an area different than her/his primary position/business unit.
• Update SOPs for assigned department as needed.
IV. Knowledge Requirements:
Education or Equivalent:
• High School diploma or equivalent required.
• Previous manufacturing experience and work in a GMP regulated industry preferred
Knowledge/Skills Requirements:
• Basic computer skills including Windows navigation and data entry.
• Must be able to read, write and communicate in English.
• Ability to read, interpret and execute written instructions.
• Ability to add, subtract, multiply, divide and combine units of measure. Ability to calculate fractions and decimals.
JD – Operator, Finishing – Revised February 2021
• Ability to solve practical problems.
• Ability to interpret and perform work against a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to multi-task and meet deadlines under pressure
Physical/Mental Requirements:
• Individual may be required to sit intermittently, stand regularly, walk regularly and consistently lift to 30 pounds; no lifting greater than 44.09 pounds without assistance, for a work period of up to 12-hours.
• Ability to push and/or pull on average 144 kg (approximately 460 pounds).
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Company’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Read written documents and frequent use of a computer monitor.
• In addition, will be required to operate industrial machinery.