Senior QA Compliance & GxP Auditor

Supernus Pharmaceuticals; Alabama; On-site; USD 90,000 - 108,000; Full time

Benefits offered by this job

Health, dental, vision benefits

401k company match

Company paid life insurance

Stock equity awards

Employee stock purchase program

Discretionary annual bonus program

Job summary

Supernus Pharmaceuticals seeks a Quality Assurance professional to perform diverse QA activities and maintain compliance with U.S. regulations and internal standards. This role emphasizes audits, deviations reviews, CAPA, and change controls to ensure product quality.

Responsibilities include oversight of suppliers, review of GxP records, assisting in regulatory inspections, and supporting product release. The candidate should have a BS in life sciences and 4+ years in GMP/GCP environments, with

Qualifications

• B.S. in a life sciences discipline.
• Minimum of 4+ years in GMP and/or GCP environments.
• Comprehensive understanding of GMPs, GCPs, GLPs and their applications.
• Proficient in Microsoft Office; strong writing and communication skills.

Responsibilities

• May manage and perform internal and external GxP audits, GCP and GLP audits, investigation site audits and internal bioanalytical audits as directed by management.
• May provide oversight of suppliers (CMOs, distributors, laboratories, GMP service providers, GLP and GCP vendors) as directed by management.
• Reviews and approves internal and external deviations, investigations, OOS, CAPA, and change controls.
• Reviews documentation related to GCP and GLPs.
• Reviews GxP records (e.g., process validation, equipment qualification, software validation) for compliance with FDA regulations, internal company standards, and others as applicable.
• May review analytical method validation protocols, technical reports, stability protocols and respective reports.
• May review and approve clinical and bioanalytical protocols and reports.
• Revises and maintains the QA compliance systems in accordance with U.S. regulations and internal standards to ensure the quality of clinical trial material being produced.
• Initiates new or revises existing SOPs for corporate QA as needed. Reviews SOPs from a compliance point of view.
• Stays current with changes, amendments to the CFR and/or FDA guidance documents to ensure that Supernus' compliance policies and procedures are up to date.
• Assists in all regulatory agencies' inspections regarding Supernus products.
• Assists QA in product release, when needed.
• Occasionally participates in project meetings, company task force, and compliance initiative teams, to provide the QA perspective and technical support as needed.
• Other duties as assigned.

Skills

Quality Assurance

GxP Knowledge

Documentation

Audit coordination

Communication skills

Technical writing

Independent worker

Education

B.S. in Life Sciences

Tools

Microsoft Office Suite

Job description

Supernus Pharmaceuticals seeks a Quality Assurance professional to perform diverse QA activities and maintain compliance with U.S. regulations and internal standards. This role emphasizes audits, deviations reviews, CAPA, and change controls to ensure product quality.

Responsibilities include oversight of suppliers, review of GxP records, assisting in regulatory inspections, and supporting product release. The candidate should have a BS in life sciences and 4+ years in GMP/GCP environments, with