Lead Machine Operator - Formulated Solutions

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

· Lead a manufacturing team of Production Assemblers safely through the production process assuring quality and efficiency standards are achieved at all times.

· Assure all required documentation is properly completed and in compliance with company policy and federal regulations.

MAJOR DUTIES AND RESPONSIBILITIES:

· Operate filling and packaging equipment.

· Receive production goals and requirements from area Production Supervisor in order to maintain the production schedule.

· Ensure that shift start times and end times are adhered to. Report issues to area Supervisor.

· Retrieve Batch Records and other needed documents from the quality department.

· Review all assigned Batch Records to assure your understanding. Request support or training when needed.

· Assure all material have been properly picked to the production order.

· Set-up production line for specific production requirements and standards as directed by the batch record. This includes mechanical assembly of some equipment.

· Review materials for correctness against the Batch Record Bill of Materials. Report discrepancies to area Supervisor.

· Check that all assemblers are properly signed into the batch record and punched into the production order during its duration.

· Assemble Production Assembler team, discuss production process, quality attributes and manufacturing goals.

· Assure you and all employees are using the proper PPE for the task that are being performed.

· Review all safety instructions in the batch record with Production Assemblers.

· Assigns personnel to cleaning and production tasks based on their training and abilities.

· Comply with all quality, safety and company policies. Report concerns to area Supervisor.

· Monitor quality attributes, perform quality checks as required by the batch record.

· Report quality and safety concerns to area Supervisor. Stop production, if necessary, to ensure the safety of employees and quality of the product being produced.

· Before, during and after assure compliance with all batch record requirements are achieved.

· Document all data and task as required by the batch record.

· Maintain all equipment and area logs.

· Maintain cleanliness of equipment and area.

· Communicate with other teams i.e. management, quality and maintenance as needed.

QUALIFICATION:

A. Required

· Dependable transportation.

· Can work independently or with a team.

· Speak and understand English fluidly.

· Communicate clearly verbally and in writing.

· Work shifts that may exceed 10 or 12 hours when asked.

· Work weekends.

B. Preferred Additional

· Past packaging production experience.

· CGMP, 5-S, Clean Room experience.

· Past production work experience of 5 plus years.

CRITICAL SKILLS AND ABILITIES:

· Ability to operate complex production machinery and related equipment.

· Ability to lead, direct and train others on task that will be performed.

· Ability to assist in diagnosis and repair of malfunctioning machines.

· Ability to follow written/verbal instructions.

· Ability to keep accurate records.

· Must be able to stand in one place for length of shift.

· Perform basic math functions i.e. addition, subtraction and division.

· Perform counts on components.

· Place components on other components while they move on a conveyor.

· Follow written/verbal instructions.

· Write clearly and legibly.

· Lift 35 – 50 pounds on a regular basis.

· Use of a scanner, calculator or computer.

COMPUTER SKILLS:

Technical Skills and Experience

MS Outlook, Word, Excel.

Education and/or Training

· High School diploma or equivalent.

· First aid / CPR.

· Computer basics / calculator.