Job Description

The work we do at BioTechnique has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what’s possible.


POSITION SUMMARY:

The Quality Assurance Associate is responsible for ensuring compliance with all quality standards and guidelines. The QA Associate will analyze systems and procedures, identify any potential issues, and work with the Quality Team to ensure process improvement and resolutions. This is a remote position supporting Eastern Standard Time.


DUTIES AND RESPONSIBILITIES:

• 
  Develop and assist in Quality Systems and Meteorology systems as needed.
  
• Assist in software validation and runs quality systems accordingly.
  
• Support of documents for SOPs, test methods, raw material specification, protocols, and related control documents.
  
• Follows safety initiates and assist upper management with the compliance of SOPs and specifications
  
• Perform a variety of activities to ensure compliance with applicable regulatory requirements.
  
• Assists to maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  
• Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
  
• Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) daily.
  
• Performs independent technical review of documentation during and post-execution of cGMP activities.
  
• Ensures all specifications are met and that applicable requirements are completed and acceptable.
  
• Analyzes and reports findings to appropriate departments.
  
• Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of Quality Systems.
  
• Implements continuous improvement efforts as it relates to QA activities.
  
• Other duties are required.

Requirements

• Requires a Bachelor or higher degree from an accredited four-year university, preferably in sciences or engineering.
  
• 3-5 years of relevant experience. Quality Assurance experience preferred.
  
• Experience following regulatory guidelines for pharma industry and cGMPs.
  
• Experience with quality management systems.
  
• Must be detail-oriented and able to demonstrate a high standard of integrity.
  
• Must have a desire to demonstrate excellence by setting high standards.
  
• Must have an understanding and application of QA principles, concepts, industry practices, and standards.
  
• Strong knowledge of relevant regulations and guidance required in order to act as a resource for colleagues.
  
• Strong verbal, technical writing, time management and interpersonal skills are required.
  
• Computer competency is required.
  
• Strong independent judgment and decision-making abilities required.
  

#LI-AK1
Requires a Bachelor or higher degree from an accredited four-year university, preferably in sciences or engineering. 3-5 years of relevant experience. Quality Assurance experience preferred. Experience following regulatory guidelines for pharma industry and cGMPs. Experience with quality management systems. Must be detail-oriented and able to demonstrate a high standard of integrity. Must have a desire to demonstrate excellence by setting high standards. Must have an understanding and application of QA principles, concepts, industry practices, and standards. Strong knowledge of relevant regulations and guidance required in order to act as a resource for colleagues. Strong verbal, technical writing, time management and interpersonal skills are required. Computer competency is required. Strong independent judgment and decision-making abilities required. #LI-AK1