Ops Investigation Coordinator (On-Site)

Purpose and Scope

The Operations Investigations Coordinator serves in the role of supporting investigations and documenting deviations for Manufacturing and Operations procedures and processes.

Essential Duties & Responsibilities

• Initiate and own minor/major deviations and trend investigations for the Manufacturing team, ensuring timely initiation, investigation, and closure of investigations using the EQMS system.
• Maintain investigation qualification status and attend RCA/investigation and technical writing related training as required.
• Create SMART CAPAs and Effectiveness Checks, resulting in the reduction of deviations and recurrences using the EQMS system.
• Create, revise and review work instructions (WIs), standard operating procedures (SOPs) and batch records utilizing the EDMS system.
• Prepare and present deviation reports to management, including (but not limited to) Quarterly Trend Report.
• Create and manage dashboards for Manufacturing deviations, CAPAs and Effectiveness Checks within the Veeva system.
• Act as a technical resource and point of contact for deviations related to the Manufacturing process.
• Perform real-time troubleshooting and containment of events with in-depth understanding of product and process impact.
• Interact closely and effectively with project teams and across departments.
• Identify opportunities for process improvements to prevent deviations and enhance overall quality systems.
• Support implementation of CI initiatives to optimize deviation management processes.
• Provide administrative and technical support for Operations Investigations initiatives as required.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of Root Cause Analysis and 5 Whys methodology.
• Understanding of ALCOA+ and data integrity principles.
• Excellent verbal and written communication skills.
• Excellent attention to detail for documentation.
• Proficient in Microsoft Office (Excel, Word, Outlook).
• Ability to build cross functional relationships and influence outcomes.
• Ability to lead cross functional groups to problem solve, gain consensus, and drive effective improvement.
• Ability to grasp the technical expertise required for current products/processes in order to support Manufacturing functions per business needs.
• Thorough knowledge of cGMP and application to pharmaceutical manufacturing.
• Basic knowledge of GDP and QA/QC principles and concepts.
• Strong knowledge of word processing, graphics and spreadsheet programs.
• Ability to manage and prioritize multiple projects and tasks, demonstrating strong organization and time management skills.
• Ability to work on short and long-term projects simultaneously and meet timelines.
• Ability to work well independently and with others.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree preferred; preferably in an engineering or scientific discipline.
• Two or more years of experience in a pharmaceutical or regulated industry in quality assurance, production, engineering, or formulation development.
• Experience with statistical trending and database programs preferred.

Working Conditions

• Working conditions are typical for an office environment.

Compensation and Benefits

• Pay: $23.00
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.