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:
Assume responsibility for and exercise leadership and initiative in all matters affecting packaging operations within the value stream. Exhibit strong ownership of manufacturing operations, using a hands-on approach to management. Demonstrate proactive, positive, “can-do” leadership by setting an example for subordinates to follow.
MAJOR DUTIES AND RESPONSIBILITIES:
- Direct and coordinate the execution of manufacturing operations and schedules based on sales requirements and value stream capacity.
- Plan, organize and manage employees, equipment, and other assets in order to meet quality, regulatory objectives, production schedules, and cost targets.
- Assist in developing and implementing realistic production schedules. Schedule overtime and/or variations in work schedules to meet production objectives.
- Work overtime, split shifts, and weekends as needed. Work before and after shift to prepare, organize and complete packaging operations commitments as required.
- Openly communicate with subordinates, peers, and others to clarify and meet all manufacturing goals.
- Represent company management to subordinates. Assure company goals are achieved.
- Understand process and product quality objectives and implement manufacturing processes to maintain regulatory compliance and achieve improvement goals. Stop production when required and make or arrange adjustments in order to correct/prevent deficiencies.
- Help implement and enforce Safety Programs. Participate in Safety objectives and assist in the implementation of corrective/preventive actions. Train employees on general and task-specific safety rules and reporting requirements. Assist EHS in maintaining safety programs and records where needed.
- Enforce all company policies, dress codes, attendance rules, safety procedures, etc.
- Encourage subordinate growth and participation in improving operations. Conduct ongoing and formal employee evaluations - providing feedback to employees as required. Implement rewards and discipline/reprimands per company policy.
- Maintain and develop CGMP practices, oversee AOP, 5-S initiatives.
- Track and Analyze production data in relation to key performance indicators in order to continuously improve processes.
- Safely manage and monitor the creation of material scrap and Hazardous Waste materials. Assure proper handling of these materials.
- Write, Review and Approve for packaging processes Batch Records, SOP’s and
- Work Instructions as well as develop process flow drawings.
QUALIFICATIONS:
Required (i.e., knowledge, prior experience)
- Ability to lift 15-35 pounds on a regular basis.
- Ability to stand for long periods of time on a regular basis
- Familiarity with CGMP methodology.
- Understanding of 5-S initiatives and Lean Manufacturing.
- Proficient in Microsoft Word and Excel
- Mentoring and developing subordinates’ skills.
- Labor Scheduling and resource planning.
Preferred Additional
- Experience with liquid packaging methodology i.e., food, cosmetic industrial products packaging. Including, filling, capping, labeling, coding, cartooning, and quality procedures for adequate monitoring.
- Packaging machine operations knowledge. Feed tables, induction heating, filling, capping, coding, bundling, conveying, cartooning, labeling etc.
- Processes mapping/design for manufacturing / packaging lines.
- Understanding of Bill-of-Materials (BOM) / Inventory and Controls
CRITICAL SKILLS AND ABILITIES:
- Ability to operate production machinery and train others in effective and safe machine operations. Must be able to assist in diagnosis and repair of malfunctioning machines.
- Ability to effectively manage regular and temporary factory personnel.
- Ability to communicate effectively at all levels.
- Basic math is required to understand, track and implement production schedules.
- Excellent organizational skills in order to facilitate optimal use of people, equipment, materials and facilities.
- Ability to remain calm and productive in a fast-paced, customer-focused environment.
- Flexibility and willingness to make and implement rapid changes as needed to accommodate customer and business changing priorities.
- Ability to understand, use, and read precision measurement tools including pressure/vacuum gauges, micrometers, gram scales/balances, and torque wrenches.
- Lead by example and educate employees in the fundamentals of manufacturing, materials, machines, environment and people.
- Participate in and hold meetings for information sharing, training, employee growth and development.
Education and/or Training
High school diploma or equivalent. Post high school education and/or training highly desirable. Training and experience in an FDA-regulated industry is highly desirable. Computer literate. First-Aid / CPR. Knowledge of CFR-21, 29, 40, 49. Comprehension in the areas of plant infrastructures, power, air, steam etc.
Shift: 3rd (11:00 pm - 7:30 am)
