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 (PA-2) 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