Supervisor, Quality Disposition

Curia • Town of East Greenbush, NY

7h • $83,000 - $104,312 • Onsite

About The Position

The Quality Disposition Supervisor will be responsible for the disposition of intermediates, API’s and incoming materials. This role will require leading the team responsible for batch dispositions and will also lead the site disposition reviews to meet supply commitments. Acts as a primary gate keeper for the disposition process at the site, ensuring batch record reviews are completed in a compliant manner, all deviations impacting the disposition are closed, QC data is reviewed per the procedures, all open change controls and CAPAs tied to the batch disposition are assessed and impact is documented. Ensures the breakdown/demand maintenance workorders impacting the batch are reviewed prior to the disposition and Quality impact assessment is documented. Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer-focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Requirements

• Bachelor’s degree in science or related study
• Minimum of six (6) years of GMP experience in an FDA regulated pharmaceutical environment including minimum of four (4) years of experience in a Quality disposition reviews in a supervisory role
• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members, sitewide
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Ability to work promptly and under pressure to meet customer and business deadlines associated with batch record lot release
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Responsibilities

• Acts as the point of contact for product disposition
• Be able to objectively and comprehensively review disposition packages and drive Quality decisions related to product disposition based on data, strong technical & scientific rationale, data integrity requirements, compliant to regulatory and site procedural requirements
• Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines
• Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-New York client products
• Interfaces with the cross functional departments to resolve any comments from the batch record reviews in a compliant manner
• Key point of contact for addressing product disposition related questions in customer audits and regulatory inspections
• Will act as subject matter expert for all quality issues related to batch release
• Will be responsible to develop Quality disposition and batch record reviewer qualification program
• Play a key role in creating training feedback loop from batch records reviews with manufacturing and other cross functional teams to drive continuous improvements

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401k program
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Manager