Quality Specialist

Quality Assurance SpecialistPosition DetailsJob Title: Quality Assurance SpecialistEmployment Type: ContractSchedule: Monday-Friday, 1st ShiftLocation: 100% OnsitePay Rate: $35.00-$39.00/hourKey ResponsibilitiesManage and maintain quality documentation and records within the Quality Management System (QMS).Support compliance with applicable quality standards and regulatory requirements.Assist with internal and external audits to ensure audit readiness and successful outcomes.Collaborate with cross-functional teams to develop, review, and update standard operating procedures (SOPs), work instructions, and quality guidelines.Support quality processes including:CAPA (Corrective and Preventive Actions)Change ControlNon-Conformance InvestigationsRisk ManagementRoot Cause AnalysisReview and approve customer projects for delivery.Support the qualification, maintenance, calibration, and control of laboratory instruments and equipment.Partner with both internal stakeholders and external customers to ensure quality expectations are metAdditional Skills & QualificationsBachelor's degree in Biology, Biotechnology, Life Sciences, Chemistry, or a related scientific discipline.Experience working in a Quality Assurance, Quality Control, or laboratory environment.Familiarity with quality systems supporting:GCPISO 17025GMP (preferred)Experience participating in audits and compliance activities.Strong understanding of:Quality Management Systems (QMS)CAPA processesRoot Cause AnalysisRegulatory ComplianceProficiency with Microsoft Office applications.Strong analytical, organizational, and problem-solving skills.Excellent written and verbal communication abilitiesJob Type & LocationThis is a Contract position based out of Waltham, MA.Pay and BenefitsThe pay range for this position is $35.00 - $39.00/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)