Hybrid QA Specialist II: CAPA & Compliance

Vector Laboratories, Inc.; Plain City (OH); Hybrid; USD 65,000 - 73,000; Full time

Job summary

Vector Laboratories, Inc. in Plain City, Ohio, is seeking a Quality Specialist II to support product release and key QMS processes across our Plain City site and the UK site.

The role is hybrid with four on-site days per week in Plain City and remote support for Quality Operations in the UK, plus about 10% travel to other Vector locations.

The successful candidate will coordinate deviations, NCMs, CAPAs, audits, and data trending, driving continuous quality improvements.

Qualifications

• Minimum 2 years of direct experience in Quality Assurance supporting Deviation/NCM/Change Control and CAPAs.
• Strong knowledge of ISO 9001 requirements.
• Minimum BS Degree in Bioscience, Chemistry, or a similar science discipline.
• Experience with NetSuite ERP and managing eQMS software, e.g. Dot Compliance.
• ISO 9001:2015 or ISO 13485:2016 certified auditor (preferred).

Responsibilities

• Review batch records and approve product release in the ERP system (NetSuite) in accordance with established procedures.
• Own and track deviations, nonconformances (NCM), and complaint investigations from initiation to closure, including coordinating root cause analysis and ensuring timely, effective CAPA implementation.
• Support change control by partnering with operational teams to initiate change requests, perform risk/impact assessment, and coordinate stakeholder reviews through implementation and closure.
• Administer the electronic QMS (Dot Compliance), including user administration, workflow configuration support, and day-to-day system troubleshooting for the Ohio and UK sites.
• Maintain controlled quality records, ensuring accurate filing, version control, retention, and retrieval in accordance with record control requirements.
• Compile, trend, and report monthly QMS metrics using Excel logs and eQMS data; elevate adverse trends and recommend improvement actions.
• Support quality improvement initiatives by developing action plans, tracking deliverables, communicating status, and driving timely completion of agreed actions.
• Prepare for and support customer, internal, and certification audits, including hosting audit activities, coordinating responses, and tracking corrective actions to closure.
• Promote a strong quality culture by supporting QMS training, coaching cross-functional partners on process requirements, and reinforcing compliance expectations.

Skills

Quality Assurance

ISO 9001 knowledge

Communication skills

Organizational skills

Problem solving

Team collaboration

Education

BS Degree in Bioscience or Chemistry

Tools

NetSuite ERP

eQMS Dot Compliance

Job description

Vector Laboratories, Inc. in Plain City, Ohio, is seeking a Quality Specialist II to support product release and key QMS processes across our Plain City site and the UK site.

The role is hybrid with four on-site days per week in Plain City and remote support for Quality Operations in the UK, plus about 10% travel to other Vector locations.

The successful candidate will coordinate deviations, NCMs, CAPAs, audits, and data trending, driving continuous quality improvements.