FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Quality Assurance Specialist II
KCAS Bioanalytical & Biomarker Services. Independently perform Quality Assurance review and approval of documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, regulatory compliance, and scientific documentation review, with a strong focus on GLP standards and continuous improvement. Capable of managing multiple audits and providing training to team members while ensuring data integrity and accountability.
Highest-signal resume keywords
Quality Assurance ExperienceGLP KnowledgeRegulatory ComplianceAudit ManagementScientific Documentation Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceRegulatory RequirementsSOP InterpretationData AnalysisQuality AuditsCAPA ReviewDocument ReviewQuality SystemsDatabase ManagementContinuous Improvement
Soft Skills
Attention to DetailStrong Communication SkillsOrganizational SkillsCollaborationTraining and Guidance
Tools & Technologies
Quality Systems SoftwareDatabasesRegulatory Guidance Documents
Industry Keywords
PharmaceuticalBiotechnologyCROBioanalytical LaboratoryQuality EventsInvestigationsDeviationsClient InspectionsInternal InspectionsRegulatory Inspections
About the role
Key responsibilities & impact- Independently perform Quality Assurance review and approval of documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance
- Conduct QA audits and inspections and communicate findings to Study Directors, Principal Investigators, management, and other stakeholders
- Review deviations, investigations, corrective and preventive actions, and other quality events, providing guidance on quality and regulatory requirements
- Review SOPs and controlled documents and support continuous improvement of QA processes and quality systems
- Maintain QA files, records, databases, and trending information; identify potential quality or compliance trends
- Partner with scientific and operational teams to resolve quality and compliance issues
- Support audit and inspection readiness and participate in client, internal, and regulatory inspections
- Provide guidance and training to less experienced team members
- Independently manage multiple audits, reviews, and assignments while meeting timelines
- Support the company brand, mission, vision, and values
- Perform quality assurance activities supporting compliance of scientific and bioanalytical work with regulatory requirements, policies, and procedures
Requirements
What you’ll need- Bachelor’s degree in a scientific, quality, or related field
- At least 2–3 years of relevant Quality Assurance, regulated laboratory, pharmaceutical, biotechnology, CRO, or related experience
- Working knowledge of GLP and applicable regulatory requirements, guidance documents, and quality systems
- Experience reviewing scientific documentation, data, protocols, reports, or other regulated records for accuracy and compliance
- Experience conducting or supporting quality audits and inspections
- Experience reviewing deviations, investigations, CAPAs, or other quality events
- Strong analytical skills and attention to detail
- Strong written and verbal communication skills
- Strong organizational skills and ability to independently manage multiple assignments, audits, and priorities
- Ability to interpret and apply SOPs, regulatory requirements, and established quality procedures
- Ability to collaborate with scientific, operational, and cross-functional teams
- Strong computer skills and ability to work with quality systems, databases, and applicable software
- Demonstrated commitment to quality, data integrity, accountability, and continuous improvement
- Preferred: Quality Assurance experience within a CRO, pharmaceutical, biotechnology, or bioanalytical laboratory environment
- Preferred: Experience supporting GLP-regulated bioanalytical studies
- Preferred: Experience participating in client or regulatory audits and inspections
- Preferred: Experience providing training or guidance to less experienced Quality Assurance staff
Benefits
Comp & perks- Company-sponsored events, including food trucks, family days, and spirit days
- KCAS University career development
- Wellness, inclusion, and community outreach engagement opportunities
- Stock ownership program
- Access to the latest technology
- Paid time off to volunteer