Quality Analyst

Quality Analyst I

Actively interviewing for multiple Quality Analysts to join leading company in tissue manufacturing and surgical innovation in Vandalia, OH!

The Quality Analyst I is responsible for performing quality control (QC) inspection and disposition of materials and products according to specifications. This role involves conducting QC inspections using measuring instruments and inspection methods where applicable. The Quality Analyst ensures that any non-conforming materials or products are managed according to the Quality System policies and procedures to maintain compliance with FDA, OSHA, and ISO regulations and standards.

The position requires performing various tasks under limited supervision.

• Perform reviews of batch production 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 (EM) testing program.
• Assist teams in coordination of problem-solving and root cause analysis for quality events.
• Ensure the development, review, and release of quarterly EM trending reports, and bring significant trends to management's attention.
• Provide input based on knowledge and experience with batch release requirements.
• Provide Quality Management System (QMS) operations support to all CGMP departments.
• Conduct Quality Control activities at processing or distribution sites, including inspections of incoming materials, in-process, and finished products.
• 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 EM testing results.
• Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies.
• Assist in reviewing and approving equipment qualifications.
• Assist in reviewing Calibration and Preventative Maintenance reviews.
• Assist in hosting onsite regulatory audits and inspections.

• Knowledge in biology, human tissue, and skin processing.
• Experience with GMP, GDP, or GXP within a Medical Device, Pharmaceutical, or Tissue commercial organization.
• Familiarity with FDA-regulated environments, particularly medical device, human tissue, or pharmaceutical manufacturing.
• Proficiency in Microsoft Excel.
• Experience writing Standard Operating Procedures and Work Instructions.
• Understanding of Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations.

• Bachelor's Degree in a Life Science discipline or related field.
• Minimum of 1-2 years of relevant industry experience.
• Experience in an FDA-regulated environment is preferred.

This position involves mostly desk-based work with some inspection duties. The role requires occasional entry into clean rooms and labs, necessitating comfort working around human tissue. The work schedule includes shifts: 1st shift (M-F 7a-3:30p), 2nd shift (M-F 3p-11:30p), and 3rd shift (M-F 11p-7:30a). Flexibility with shift times is needed. The role is based in a brand-new, state-of-the-art facility in Vandalia, OH.

This is a Contract position based out of Vandalia, OH.

The pay range for this position is $25.00 - $26.50/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)

This is a fully onsite position in Vandalia, OH.

This position is…