PSC Biotech Jobs Hiring Now

• Review batch records, logbooks, and other GMP documentation for accuracy, completeness, and compliance.
  
• Provide routine Quality Assurance oversight of sterile manufacturing and supporting operations.
  
• Initiate and support deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls.
  
• Support root cause analyses, impact assessments, and quality risk assessments.
  
• Review and approve GMP documentation within assigned level of authority.
  
• Provide QA support for aseptic processing and contamination-control activities.
  
• Support environmental monitoring, aseptic process simulations (APS)/media fills, and sterilization activities.
  
• Support qualification and validation activities to ensure compliance with applicable quality requirements.
  
• Identify, document, and escalate potential GMP, product quality, and compliance concerns.
  
• Support internal audits, customer audits, and regulatory inspection readiness activities.
  
• Collaborate cross-functionally with Manufacturing, QC, Engineering, Validation, Warehouse, and other departments to address quality and compliance needs.

Requirements

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or a related technical discipline.
  
• 2+ years Experience working in a GMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or related manufacturing environment.
  
• Knowledge of GMP requirements and quality systems within a regulated manufacturing setting.
  
• Familiarity with deviations, investigations, CAPAs, change controls, and quality risk management.
  
• Understanding of batch record and GMP documentation review practices.
  
• Familiarity with sterile or aseptic manufacturing operations, environmental monitoring, APS/media fills, sterilization, and contamination control.
  
• Ability to identify and appropriately escalate quality and compliance concerns.
  
• Strong attention to detail, organizational skills, and written and verbal communication skills.
  
• Ability to collaborate effectively across Quality, Manufacturing, Engineering, Validation, QC, Warehouse, and other functional groups.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
  
• 401(k) and 401(k) matching
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Fitness Perks and Discounted Rates
  
• Financial Perks and Discounts