Quality Assurance Disposition Specialist

Curia • Rensselaer, NY

11h • $97,100 - $121,000 • Onsite

About The Position

Quality Assurance Dispositioner Specialist in Rensselaer, NY with relocation assistance. Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Quality Assurance (QA) Dispositioner Specialist is responsible for the quality disposition of incoming materials, intermediates, and Active Pharmaceutical Ingredients at the Rensselaer site. This role includes reviewing manufacturing batch records, cleaning batch records, analytical batch records, and other supporting documentation to support batch disposition. The QA Dispositioner Specialist plays a critical role in ensuring dispositioned product batches conform to GMP requirements and site procedures.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

• Bachelor’s degree in Life Science or related field
• Minimum 5 years’ experience in quality operations, and batch record reviews in GMP and FDA regulated Drug Substance or Drug Product manufacturing facilities
• Strong knowledge of GMP, GDP, and Data Integrity requirements, including current regulatory understanding and best practices (e.g., ICH Q7, 21 CFR Part 211.192)
• Excellent verbal and written communication skills
• Focused self-starter with attention to detail
• Team-oriented, but able to work independently and proactively
• Ability to multi-task
• Strong problem solving and organizational skills
• Strong critical thinking skills, including familiarity with root-cause analysis
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Responsibilities

• Review manufacturing and cleaning batch records for conformance, with GMP and GDP requirements, including but not limited to the following: Review batch records to verify that GDP requirements are addressed in accordance with site procedures. Verify that yield and reconciliation calculations are accurate and within established limits. Confirm that all critical process parameters have been met. Review open change controls specific to the product under disposition to ensure there is no impact to batch disposition. Verify that all deviations impacting the product lot under disposition have been identified, investigated, and approved. Ensure equipment used during manufacturing was within calibration and that any out-of-tolerance calibration events were investigated. Confirm that all line clearance requirements were met prior to the start of manufacturing. Ensure all corrections identified during batch record review are appropriately addressed.
• Review analytical batch records for GDP compliance, conformance to specifications, and completeness.
• Perform lot disposition in the ERP system once batch record and disposition requirements have been met in accordance with approved site procedures.
• Critically review various documentation types to ensure completeness, accuracy, and compliance with the applicable batch record requirements and SOPs.
• Escalate issues, as appropriate for batches pending disposition.
• Communicate effectively with cross-functional departments to support on-time disposition and keep direct management informed of batch disposition progress.
• Perform duties under limited supervision and in accordance with standard operating procedures.
• Collaborate with Manufacturing to resolve batch record discrepancies or errors related to Good Documentation Practices.
• Work collaboratively within the Batch Disposition team, the Quality department, and with cross-functional partners, including Manufacturing Operations, Technical Support, Supply Chain, and Planning.
• Other duties, as necessary

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 with matching contributions
• Learning platform
• Relocation assistance

What This Job Offers

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