Quality Assurance Specialist

• Provide QA support to areas of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including:
  

• Support the tactical QA operations - assess, evaluate, and review operations on the floor (as defined above) against current Good Manufacturing Practices (cGMPs) to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.
  
• Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet FDA/EU regulatory standards.
  
• Provide guidance to all GMP areas (i.e., Manufacturing, Quality Control, etc.) to ensure compliance with all applicable regulations.
  
• Responsible for providing quality oversight to the change management system for complex minor and major classified change controls.
  
• Identify, classify, and report deviations, as appropriate. Support and drive plan development, verify any changes adhere to regulatory compliance and SOPs.
  
• Support complex major deviations and/or complaints. Support the execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
  
• Ensure all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs, SOPs, current manufacturing regulations, and site procedures.
  
• Collaborate closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
  
• Assist in resolution of issues identified. Information must be proactively communicated across QA and the business including the on-going training of junior team members.
  
• Ensure all specifications are met and that applicable requirements are completed and acceptable. Analyze and report findings to appropriate departments.
  
• Implement continuous improvement efforts. Work closely with cross functional teams in the assigned area to recognize opportunities for improvement and drive change through the use of Quality Systems.
  
• Perform technical review of documentation during and post-execution of cGMP activities.
  
• Communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures, as needed.
  
• Participate in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
  
• Implement continuous improvement efforts.
  
• Fosters quality collaboration among the site and QA staff.
  
• Support the training and development of junior team members.
  
• Additional duties may be assigned from time to time.

Benefits

• Medical, Dental, and Vision - BioTechnique 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
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts