What are the responsibilities and job description for the Quality Assurance Manager position at Advanced Bio-Logic Solutions Corp?
Location: Remote - Nashville, TN (PST preferred)
Employment Type: Contingent Worker (Contract, W2)
Contract Length: 3 months (possible extension)
Compensation: $54/$62 per hour (based on experience)
Summary of the Role
Join a large biotech pharmaceutical leader as a remote Quality Assurance contractor specializing in Computer Systems Validation (CSV) and change control. You will support GxP computer systems initiatives, ensure documentation compliance, and drive risk-based validation processes. This role directly impacts operational compliance and system integrity within regulated environments.
Key Responsibilities
- Serve as Quality Assurance (QA) contact for Change Control related to computerized systems
- Review and approve validation deliverables including plans, requirements, testing protocols, and summary reports
- Act as a change agent and advocate for the Risk Based Validation program
- Function as subject matter expert (SME) for multiple quality processes, such as Deviations and CAPA
- Review and approve Standard Operating Procedures (SOPs) and related documents
- Conduct periodic reviews for GxP systems
- Perform software supplier evaluations as needed
- Support project initiatives and process improvements
- Present on validation topics or issues to management when required
- Support audits, inspections, and other quality-related duties as necessary
Required Experience & Skills
- Mandatory Computer Systems Validation (CSV) experience
- Experience with validation and change control (risk-based validation and/or Computer System Assurance knowledge highly preferred)
- Strong documentation, operational, and compliance skills
- Proactive, engaged, and professional in handling escalations and de-escalating conflicts
- Excellent written and verbal communication skills
- Strong team collaboration and leadership abilities
- Ability to interpret and apply GMP, GLP, GCP, and GPvP regulations
- Strong organizational skills to see assignments through completion
Preferred Qualifications
- 5 years’ experience in a regulated industry (e.g., biotechnology, medical device, aerospace) in a similar role
- Experience working with Veeva or safety systems
- Knowledge of industry-wide regulatory systems
- Strong problem-solving and risk assessment abilities
- Demonstrated knowledge of industry and business principles
Top 3 Must Have Skills
1. Prior experience with Computer Systems Validation and risk-based decision making
2. Project management experience (preferred)
3. Ability to evaluate documentation and operations according to company and regulatory guidelines
Day-to-Day Responsibilities
- Review and approve validation documents such as validation plans, specifications, user and functional requirements, testing protocols, summary reports, and traceability matrices
- Review and approve operational and administrative SOPs
- Review and approve change controls as QA contact or owner
- Provide and present risk-based validation training and workshops
- Assist or lead validation strategy and risk-based requirements profiling
- Work independently with minimal supervision
Basic Qualifications
- Doctorate degree
- Master degree and 3 years of experience
- Bachelor degree and 5 years of experience
- Associate degree and 10 years of experience
- High school diploma / GED and 12 years of experience
This posting is for Contingent Worker, not an FTE
Salary : $54 - $62