Senior Manufacturing Formulator

Roche • Tucson, AZ

2d • Onsite

About The Position

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.

Requirements

• Associate's degree + 3 years of work experience required.
• Experience in a regulated industry required.
• Experience in GxP required.

Nice To Haves

• Bachelor's degree + 2 years of experience preferred.

Responsibilities

• 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.
• 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.
• 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 Roche policies and procedures.
• Escalates all quality and production deviations to leadership.
• 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.
• 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.
• 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.
• 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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree