Quality Assurance Specialist

Description

About VaLogic Bio, LLC

VaLogic Bio provides crucial technology and compliance services to clients in the life sciences and biotechnology industries; helping organizations establish and remain FDA compliant.

Our client services allow scientists to focus their time on the advancement of their life-enhancing therapeutics. This is done through a suite of services that include advisory and facility design, equipment calibration and validation, commissioning, preventative maintenance, laboratory and cleanroom environmental monitoring, and SaaS technology for compliance and continuous monitoring.

Job Title: Quality Assurance Specialist

Job Purpose:

To ensure the quality and compliance of VALOGIC BIO LLC's products, services, and processes by implementing, and maintaining quality assurance programs and procedures. This role will involve meticulous attention to detail, strong analytical skills, and a commitment to upholding regulatory standards within the biotechnology or pharmaceutical industry (depending on VALOGIC BIO LLC's specific area of focus).

Key Responsibilities:

• Implement, and maintain quality assurance programs, procedures, and documentation in accordance with relevant industry regulations and standards (e.g., GMP, GLP, ISO).
• Conduct regular internal audits and inspections to assess compliance with established quality systems and identify areas for improvement.
• Assist in investigation of deviations, non-conformances, and customer complaints, determining root causes and implementing corrective and preventive actions (CAPA).
• Participate in the development and review of standard operating procedures (SOPs) to ensure clarity, accuracy, and compliance.
• Collaborate with other departments (e.g., Lab Services, Validation, Certification, Calibration) to address quality-related issues and promote a quality-conscious culture.
• Maintain accurate records of quality assurance activities, including audits, inspections, deviations, and CAPA.
• Stay up-to-date on current industry regulations, guidelines, and best practices related to quality assurance.
• Provide training to employees on quality assurance principles, procedures, and documentation.
• Contribute to continuous improvement initiatives within the quality management system.
• Support regulatory inspections and audits by providing requested documentation and information.
• Perform risk assessments to identify potential quality risks and develop mitigation strategies.
• Review and approve quality control test results and release finished products.
• Manage and maintain quality control equipment and instrumentation.
• May be involved in supplier qualification and auditing.
• Other duties as assigned related to quality assurance.

Required Education:

• Bachelor's degree in a scientific discipline such as Biology, Chemistry, Biochemistry, or a related field.

Required Experience:

• • Minimum of 2 years of experience in a Quality Assurance role within a regulated industry, preferably pharmaceuticals, biotechnology, or medical devices.
  • Experience with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
  • Experience in quality control testing, documentation review, and deviation investigations.
  • Experience in developing and executing quality assurance procedures and protocols.
  • Experience with quality management systems and auditing.

Required Skills and Abilities:

• • Strong understanding of quality assurance principles and methodologies.
  • Excellent knowledge of GMP regulations and guidelines.
  • Proficiency in conducting quality control tests and analyzing data.
  • Ability to interpret and apply regulatory requirements.
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and accuracy.
  • Effective communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office Suite applications.
  • Ability to maintain confidentiality and handle sensitive information.

Benefits

We currently offer a robust suite of employee benefits including:

Medical & Prescription Coverage                      Supplemental Life and AD&D

Dental Coverage                                             Short- and Long-Term Disability

Vision Coverage                                              Employee Assistance Program

Health Savings Account (HSA)                         Unlimited Paid Time Off

Basic Life and AD&D                                       11 Paid Company Holidays

EEO Statement

VaLogic Bio, LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

VaLogic Bio, LLC (VaLogic) does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to VaLogic will be considered VaLogic property, and VaLogic will not pay a fee should it hire the subject of any unsolicited resume.

Qualifications

Required Education:
- Bachelor's degree in a scientific discipline such as Biology, Chemistry, Biochemistry, or a related field.

Required Experience:
- Minimum of 2 years of experience in a Quality Assurance role within a regulated industry, preferably pharmaceuticals, biotechnology, or medical devices.
- Experience with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
- Experience in quality control testing, documentation review, and deviation investigations.
- Experience in developing and executing quality assurance procedures and protocols.
- Experience with quality management systems and auditing.

Required Skills and Abilities:
- Strong understanding of quality assurance principles and methodologies.
- Excellent knowledge of GMP regulations and guidelines.
- Proficiency in conducting quality control tests and analyzing data.
- Ability to interpret and apply regulatory requirements.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite applications.
- Ability to maintain confidentiality and handle sensitive information.

Salary : $60,000 - $80,000