Quality Assurance Disposition Specialist

About the role

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.

Responsibilities

• Review manufacturing and cleaning batch records for conformance with GMP and GDP requirements, including:
  • Verifying GDP requirements are addressed in accordance with site procedures.
  • Confirming yield and reconciliation calculations are accurate and within established limits.
  • Confirming all critical process parameters have been met.
  • Reviewing open change controls specific to the product under disposition to ensure no impact to batch disposition.
  • Verifying that all deviations impacting the product lot under disposition have been identified, investigated, and approved.
  • Ensuring equipment used during manufacturing was within calibration and that any out-of-tolerance calibration events were investigated.
  • Confirming all line clearance requirements were met prior to the start of manufacturing.
  • Ensuring 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 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.

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).

Skills

• 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.

Physical requirements

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.

• 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 environment

The 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.

• 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.
• 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, and will need to be familiar with applicable training requirements included in the customized Resources, Conservation and Recovery Act, including 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.