QA Specialist - Level 2
Randstad USA, King Of Prussia, PA, United States
Job Summary
This critical role provides specialized quality oversight for the validation and qualification of advanced manufacturing processes, facility utilities, and complex equipment systems. The Specialist ensures unwavering adherence to global Good Manufacturing Practices (GMP) during the pivotal transition of novel therapeutic candidates through the Technology Transfer lifecycle. By maintaining rigorous standards in cleaning validation and system qualification, this individual plays a foundational role in ensuring the safety, identity, and purity of products destined for clinical and commercial patients. Location: King Of Prussia, Pennsylvania. Job type: Contract. Salary: $60.00 - $62.22 per hour. Work hours: 9 to 5. Education: Bachelors. Responsibilities
Quality support of Validation and Qualification Activities, such as: Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities. New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with company and regulatory standards. This includes review and approval of various tech transfer related protocols, tasks, and documentation. Review and approve validation protocols for facility services, utilities, equipment, and computer systems, at all phases of the validation lifecycle, including cleaning validation. Support PAI and regulatory inspections, as well as internal inspections and routine. Provide quality oversight of routine facility/utility spaces including housekeeping Gemba. Other duties as required to support manufacturing, right first time tech transfer, and operational quality as needed. Qualifications
Required: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Bioengineering). Required: Minimum of 2 years of experience in a GMP-regulated Quality Assurance or Validation environment. Preferred: Proven experience in Technology Transfer or New Product Introduction within the Biotech/Pharmaceutical sector. Preferred: Working knowledge of equipment qualification (IQ/OQ/PQ) and risk-based validation approaches. Skills
Good Manufacturing Practices (GMP), Process Validation, Quality Assurance (QA), Quality Control (QC) Benefits
In addition, we offer a comprehensive benefits package, including medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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This critical role provides specialized quality oversight for the validation and qualification of advanced manufacturing processes, facility utilities, and complex equipment systems. The Specialist ensures unwavering adherence to global Good Manufacturing Practices (GMP) during the pivotal transition of novel therapeutic candidates through the Technology Transfer lifecycle. By maintaining rigorous standards in cleaning validation and system qualification, this individual plays a foundational role in ensuring the safety, identity, and purity of products destined for clinical and commercial patients. Location: King Of Prussia, Pennsylvania. Job type: Contract. Salary: $60.00 - $62.22 per hour. Work hours: 9 to 5. Education: Bachelors. Responsibilities
Quality support of Validation and Qualification Activities, such as: Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities. New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with company and regulatory standards. This includes review and approval of various tech transfer related protocols, tasks, and documentation. Review and approve validation protocols for facility services, utilities, equipment, and computer systems, at all phases of the validation lifecycle, including cleaning validation. Support PAI and regulatory inspections, as well as internal inspections and routine. Provide quality oversight of routine facility/utility spaces including housekeeping Gemba. Other duties as required to support manufacturing, right first time tech transfer, and operational quality as needed. Qualifications
Required: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Bioengineering). Required: Minimum of 2 years of experience in a GMP-regulated Quality Assurance or Validation environment. Preferred: Proven experience in Technology Transfer or New Product Introduction within the Biotech/Pharmaceutical sector. Preferred: Working knowledge of equipment qualification (IQ/OQ/PQ) and risk-based validation approaches. Skills
Good Manufacturing Practices (GMP), Process Validation, Quality Assurance (QA), Quality Control (QC) Benefits
In addition, we offer a comprehensive benefits package, including medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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