RCI-ABBV-32070 Software Quality Assurance Specialist / Software Validation Analyst (21 CFR Part[...]

Rangam; North Chicago (IL); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible work schedule

Collaborative team environment

Job summary

An established technology company in Illinois is looking for a Software Quality Assurance Specialist. The role involves managing software lifecycle deliverables, ensuring compliance with FDA regulations and quality management systems. Candidates should have a Bachelor's degree in a related field and 4-7 years of relevant experience. The position offers a hybrid work model with three days on-site and two days remote, working Monday to Friday for eight hours each day.

Qualifications

• 4-7 years of experience in quality management systems or software engineering.
• Knowledge of FDA requirements and regulations, including 21 CFR Part 11.
• Experience in a regulated environment and familiarity with quality assurance activities.

Responsibilities

• Perform assessments for compliance with processes and regulations.
• Create and review project deliverables ensuring quality and compliance.
• Support project teams in planning and preparing quality documents.

Skills

Software lifecycle deliverables

Effective time management

Interpersonal skills

Analytical and troubleshooting skills

Education

Bachelor’s degree in Engineering or related field

Tools

SAP S4/HANA

TrackWise

Document management system

Job description

• Maintenance, Configuration and Implementation of data for Client's Market Authorization control system.
• Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
• SAP S4/HANA and TrackWise experience preferred.
• Good verbal and written communication skills. Knowledge or experience in computerize system validation/testing;
• The candidate is responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
• Lead or participate in various reviews, risk analyses and other software quality assurance activities with primary focus on review and approval of restrictions, configurations, and validation supporting documents.
• Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities.
• The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical and troubleshooting skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources.
• Support project teams in planning, preparation, reviewing and approval of quality documents. Create quality system documentation with guidance from technical teams following approved templates and guidelines.
• Collect and compile key quality metric data.
• Assist with processing configuration and restriction implementation within SAP S4/ HANA enterprise system.
• Ability to maintain a high degree of accuracy and analytical thinking.
• Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and suggest improvements within our quality system.
• Assist in the design of effective quality systems, procedures and/or processes to ensure compliance as well as efficiency throughout our quality system.

Required:

• Quality Management systems experience including Document management system
• Minimum Bachelor’s degree, background in software engineering or software quality assurance, Engineering or other technical/ scientific area or equivalent experience.
• 4-7 Years Experience

Daily job responsibilities they vary but overall:

• Primary focus on creating, review and approval of project deliverables, and compliance with applicable Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
• Responsible for complying with international regulatory requirements. Also, participate in various software lifecycle (SLC) deliverables reviews, risk analyses, troubleshooting business related issues and other quality assurance activities.

Are you open to look at candidates willing to relocate?

Prefer local

What are the top 3-5 skills requirements should this person have?

• Experience working with software lifecycle deliverables and ability to incorporate updates to meet the needs of the business and project teams;
• Effective time management and ability to adjust workload to meet customer needs;
• Good interpersonal skills with the ability to work collaboratively with multiple project teams of differing backgrounds
• Must be able to work 50 weeks out of the year, excluding Client holidays.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Quality Management System – Change Management module, and technical skills – implementation and configuration are preferred; Understanding of computerize system Testing.
• Hands-on professional with experience in the software lifecycle (SLC).

What type of environment is this person working in?

Individual contributor able to work independently as well as within a team

Work Schedule (Define days, # of hours)/ Is Overtime offered or required? If yes, how many ours, what impact to scheduled working hours?

Monday – Friday, 8 hours days; 40 hours a week.

Start time: 8:00 AM CST. Overtime – limited but requires manager approval.

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?

• 3 days on site (Tue, Wed, Thur) and 2 days remote (If needed, Mon and Friday onsite work is possible).

Is the worker onshore or offshore?

Onshore

Will there be Domestic and/or International Travel?

No Travel