Quality Assurance Disposition Specialist

Quality Assurance Dispositioner Specialist

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.

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 with matching contributions
• Learning platform
• And more!

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.

Essential Job Duties

• 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

Education, Experience, Certification and Licensures Required

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)

Knowledge, Skills and Abilities

• 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

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $97,100-$121,000

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

Physical requirementsThe 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.

While performing the duties of this job, the employee is regularly required to sit; use hands and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environmentThe work environment characteristics described here 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.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one's environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act.

Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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.