Job Summary
The Senior Manufacturing Formulator collaborates to produce reliable medical device products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Senior Manufacturing Formulators, responsibilities include performing weigh, mix and in process testing of chemical reagents in a regulated environment, through the manual processing or operation of automated equipment. Additionally, a Senior Manufacturing Formulator supports production by proactively recognizing, and elevating safety, equipment, and product-related issues, contributing to the achievement of production goals. They utilize validated software systems to maintain processes, batch records, and inventory control, ensuring all production related documentation is in compliance with quality system regulations. They are responsible for training new employees, sharing best practices, and ensuring team members are qualified to perform the work. A Senior Manufacturing Formulator influences, motivates and provides guidance to team members, serves as back-up Process Lead, communicates and collaborates with leadership as needed. They also have excellent communication and organizational skills, and the ability to identify opportunities that would drive the business forward while complying with quality processes and objectives. This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.
Responsibilities
Production
? Acts as subject matter expert in the formulation and production of stocks and bulk solutions by performing calculations, completing material requests and transactions, and utilizing lab equipment in controlled areas.
? Identifies improvements as work is performed to improve cycle time, quality, safety and delivery of products.
? Performs in-process testing of reagents as detailed in manufacturing formulas, troubleshoots and develops standard operating procedures.
? Supports team members with verifications including concentrations/titers, line clearance, and line closeout.
? Fulfills reservations by proactively checking open reservations, requesting material, pulling material aliquot and properly labeling material.
? Performs planning, input, and execution of validations, protocols, and scientist investigations. Initiates and leads process improvement projects.
? Contributes to the manufacturing schedule by supporting 3 or more reagent product lines (detection, molecular, special stains, antibody, bulk reagents).
? Acts as subject manager expert in validated production systems as part of manufacturing documentation and inventory management.
? Communicates and collaborates with planning, quality control, material conveyance and other production teams to expedite work.
? Partners with Process Lead to understand and execute production schedule; Ensures daily end of shift reports/pass downs are completed to ensure proper communication and synergies between shifts and teams.
? Assists with batch record reviews.
• Safety and Quality
? Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; Addresses and escalates any potentially unsafe hazards; Ensures timely reporting of safety hazards, incidents and near misses using safety reporting tools.
? Recognizes and initiates safety improvement projects, communicates and partners with SHE group and Leadership to implement.
? Navigates and understands the quality system and actively identifies quality improvement ideas or concerns to ensure we achieve our quality objectives.
? Ensures audit readiness (OSHA, NMPA, FDA, etc.); may be required to represent their team during internal audits/inspections.
? Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other policies and procedures.
? Escalates all quality and production deviations to leadership. Follows through with associated actions and communication.
? Leads and owns non-conformance investigations, reworks, and corrective actions.
? Owns, initiates, monitors, reviews, and provides feedback on document changes, including redlines.
? Adheres to 95% or above internal training compliance.
? Maintains calibrated equipment, assesses the need for new /replacement equipment, and coordinates purchase and ioq/certification process.
• Teamwork and Collaboration
? Proactively collaborates with peers on shift and with other function to ensure we exceed daily targets.
? Assists in the successful onboarding of new employees and contractors, including facilitating OJT.? Maintains train the trainer certification.
? Supports the leaders to maintain and cultivate the organization's culture.
? Collaborates with the team and leaders to achieve departmental goals.
? Communicates outside the department with manufacturing and associated organizations.
? Partners with internal and external functions to address escalations in a timely and effective manner.
? May collaborate with cross-functional teams on new production processes.
• Continuous Improvement
? Acts as subject matter expert in 6S activities; Identifies, owns and implements process improvements and continuous improvement initiatives utilizing lean tools.
? Participates in the collection of data, population and trending of daily metrics (e.g. Safety, Quality, Cost, Delivery) to identify gaps and support operational excellence initiatives and improvements.
? Identifies areas for improvement and can convey ideas to maintenance, engineering, or area leaders .Troubleshoots problems, engages appropriate support functions, and assists in implementing preventative measures.
? Actively contributes, and can represent area of responsibility in tier meetings; may facilitate meetings.
Education
Associate’s Degree Required
Bachelor’s Degree Preferred
Knowledge, Skill or Ability
Req Pref Proficiency
• Experience in basic and some specialized laboratory techniques.
• Experience in precise manual pipetting and measuring techniques.
• Experience with handling corrosive and hazardous materials.
• Demonstrated experience with Lean / Continuous Improvement.
• Experience with Google products (gMail, gSheets, gDoc, etc).
• Experience with ERP systems.
• Strong critical thinking, problem solving and analytical skills.
• Ability to work with cross-functional teams.
• Ability to read, write and comprehend English.
• Ability to work with cross-functional teams.
• Ability to be agile and accurate in a high-volume, fast paced environment.
• Strong organizational skills, planning skills and attention to detail.
• Strong communication skills - written, verbal.
• Excellent time management skills to manage multiple tasks and competing timelines.
• Ability to have prompt, regular and reliable worksite attendance.
• Ability to work effectively with a respirator and other required PPE.
• High degree of initiative with the ability to work autonomously.
• Ability to use the technology associated with the industry.
• Ability to use precision tools.
Physical conditions and PPE requirements: The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.
• Push, pull, and lift a minimum of 50 pounds.
• Perform repetitive, consistent movements of the wrists, hands, and/or fingers.
• Have good near visual acuity to perform activities throughout the processes in the assigned area. • Able to work in, on, around, over and under fixed equipment and machinery; to work with step stools and ladders; to manipulate heavy equipment, tools and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.
• This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
