Manufacturing Operator

Title: Finishing Operator

Location: St. Petersburg, FL – 33716

Duration: 1-3 months with possible extension

SHIFT - 7AM - 7PM 2-2-3 rotating shift.

Must be able to work any day of the week.

Job Description:

• To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment at Client. 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 Client.

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.