About this opportunity
Curia Aalborg ApS lists this Supervisor, Quality Disposition opportunity in city of rensselaer, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Quality Disposition Supervisor in Rensselaer, NY
Our Rensselaer site is undergoing a crucial quality transformation. This is a rare opportunity to join a highly visible project, re-engineer quality systems from the ground up, and gain unmatched regulatory exposure.
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.
Build your future at Curia, where our work has the power to save lives.
What We 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.
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
Pay Range: $102,000-$128,000/yr
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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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.