Batch Record Reviewer Jobs (NOW HIRING)

Job Description
Quality Disposition Supervisor
Summary:
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.
We proudly offer:

• 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
• And more!

Essential Duties and 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

Education and Experience:

• 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

Supervisory Responsibilities:
This role has supervisory responsibilities, involves mentoring, guiding, and advising.
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
Mathematical Skills:
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
Reasoning Ability:
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.
Computer Skills:
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
Other Skills and Abilities:

• 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

Other Qualifications:
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The essential physical demands will vary for each Curia position.
All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment:
The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.
The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
The warehouse environment is typically set at a controlled temperature, but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.
All environments may be subject to working with or being exposed to cleaning agents.
Pay Range: $83,000 - $104,312
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
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