Lead Production Operator-Concentrate Filling (Cleanroom Environment)

Keystone Industries•Gibbstown, NJ

75d•Onsite

About The Position

We are passionate about our employees and strive to create a stimulating and motivating environment with a culture that fosters mutual respect, teamwork, and career development. Join the Keystone team to build your career together. In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks, and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. This position is located in Gibbstown, NJ.

Requirements

0-1-year+ experience in a production/manufacturing environment.
Strong documentation skills; proficient in reading and completing batch cards to GMP standards for cleanroom operations.
Excellent attention to detail and a strong commitment to producing high-quality products.
Mechanical aptitude.
Strong communication skills in English (both written and verbal) to understand and follow procedures, work instructions, and safety guidelines.
Strong mathematical skills with ability to add, subtract, multiply, and divide various units of measure.
Ability to work effectively in a fast-paced, team-oriented environment.
Must be capable of wearing all required protective gear and adhering to all PPE and gowning/garbing procedures.
Willingness to work flexible hours, including shifts and overtime, as needed.
Comply with all safety regulations; maintains a safe work environment at all times.
Adhere to always wearing the proper PPE/Safety equipment.
Understand and comply with all written safety, health, and environmental procedures.
Attend all required scheduled Health, Safety and Environmental training sessions.
Participate in required Health, Safety and Environmental initiatives and programs.
Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.
Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms; balance; stoop; bend; kneel and climb; and frequently lift/move up to 50 lbs.
In addition, may occasionally be required to maneuver and move 30 to 55-gallon drums and up to 450 pounds utilizing proper ergonomic handling equipment and/or the proper techniques.

Nice To Haves

Prior Lead and cleanroom experience.
Knowledge of Good Manufacturing Practices (GMP) and Aseptic manufacturing techniques.
Previous experience working in pharmaceutical or chemical industry; cleanroom preferred.
ERP/MRP software experience.
Pallet jack and/or forklift experience.

Responsibilities

Lead and direct a team of Operators during shift operations to ensure that production goals and quality standards are met.
Oversee the setup, operation, and non-technical maintenance of batch controllers, lines, tanks, and packaging equipment for the production process.
Manage the preparation and filling of liquid batches, ensuring proper procedures are followed.
Accurately supervise the weighing of materials and ensure batch card documentation is completed per GMP/GDP standards.
Read and complete batch cards accurately, adhering to GMP standards for clean room operations.
Fill liquid batches according to established procedures and production requirements.
Accurately weigh materials and record all information on batch cards, ensuring traceability.
Transact inventory using a handheld scan gun in ERP System recording proper lot/batch numbers, quantities, and item/part numbers.
Monitor machine operations and production to ensure quality, efficiency, and safe operation.
Record and maintain production data in accordance with standard procedures.
Perform routine quality checks (torque, labels, containers, packaging, liquid levels, etc.) throughout the filling process to ensure compliance.
Ensure all documentation is clearly completed for accuracy to meet quality and regulatory standards.
Assist with equipment adjustments as necessary, under supervision, to maintain product quality and equipment performance.
Clean and sanitize filling equipment and lines following established sanitation procedures.
Maintain the clean room environment by adhering to gowning procedures and cleaning floors and surfaces according to detailed procedures.
Perform general housekeeping duties to ensure a safe and organized work environment.
Assist in spill clean-up, following designated procedures as instructed.
Prepare finished products for shipment by boxing, labeling, and staging materials according to packaging specifications and shipping requirements.
Dispose of waste properly in designated containers and complete waste logs accurately.
Perform additional duties/tasks as needed or requested by management.
Meet or exceed performance expectations based on production and quality metrics, regularly reviewed.

Benefits

Weekly Pay
Enriched Medical, Dental, and Vision Plans
Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options
401(k) Retirement Savings Plan with Safe Harbor – Employer Contribution of 3% of Gross Wages
Tuition Assistance Program
Onsite Fitness Center
Convenient Onsite Restaurant - Enjoy easy access to a restaurant located right in our building. Meals are available for purchase.
Company-Provided Term Life Insurance
Voluntary Insurance Options – Term Life, Accident, Disability, Critical Illness, and Hospital Indemnity
Paid Time Off (PTO) – Accrued time off to support work-life balance
Paid Holidays
Employee Assistance Program (EAP) – Confidential employee support services
Financial Wellness Resources
Employee Discounts & Perks – Depending on available programs
Opportunities for Career Development and Internal Growth