Quality Analyst

Quality Analyst

The Quality Analyst is responsible for performing quality control inspections and disposition of materials and products according to specifications. This role involves using measuring instruments and inspection methods, ensuring that any non-conforming materials or products are managed according to the established Quality System. The analyst must adhere to policies and procedures to ensure compliance with FDA, state OSHA, and ISO regulations and standards. This position requires performing various tasks under limited supervision.

Responsibilities

• Perform reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinate and track CAPA, NCR, and Deviation records, ensuring tasks are completed on time.
• Coordinate and track the site environmental monitoring testing program.
• Assist teams in problem-solving and root cause analysis for associated quality events.
• Develop, review, and release quarterly environmental monitoring trending reports, ensuring significant trends are brought to management attention.
• Provide input based on knowledge and experience with batch release requirements.
• Provide Quality Management System Operations support to all CGMP departments.
• Perform Quality Control activities at processing or distribution sites, including incoming material inspections, in-process inspections, and finished product inspections.
• Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provide support related to gowning qualification and training.
• Ensure timely issuance, review, and approval of Microbiology and environmental monitoring testing results.
• Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies.
• Assist in the review and approval of equipment qualifications.
• Assist in the review of Calibration and Preventative Maintenance.
• Assist in hosting onsite regulatory audits and inspections.

Essential Skills

• Bachelor's Degree in a Life Science discipline or related field.
• 0-2 years of relevant industry experience within Medical Device, Pharmaceutical, or Tissue commercial organization.
• Experience in an FDA-regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing.
• Proficiency in Microsoft Excel.
• Experience writing Standard Operating Procedures and Work Instructions.
• Knowledge of Quality System elements for CAPA, Non-Conforming Reports, and Deviations.

Additional Skills & Qualifications

• Knowledge in biology, human tissue, skin processing.
• Understanding of GMP compliance.
• Experience with tissue and cells.

Work Environment

This position involves mostly desk-based work with occasional inspection duties. The role requires entry into clean rooms and labs, so candidates must be comfortable working around human specimens. The work shift is Monday to Friday, with flexible start times between 7:30 AM and 8:30 AM, and end times between 4:30 PM and 5:30 PM. The facility is a brand-new state-of-the-art establishment located in Vandalia, OH.

Pay and Benefits

The pay range for this position is $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Vandalia, OH.

Application Deadline

This position is anticipated to close on Sep 9, 2025.