Quality Assurance Engineer II

Solstice Advanced Materials; Baton Rouge (LA); On-site; USD 85,000 - 106,000; Full time

Benefits offered by this job

Employer-subsidized Medical, Dental, V

Disability insurance

401(k) match

Parental Leave & PTO

12 Paid Holidays

Job summary

Solstice Advanced Materials seeks a Quality Assurance Engineer II to ensure quality, reliability, and performance of software products through systematic testing and quality practices. You will collaborate with developers, product managers, and stakeholders to design, execute, and improve test strategies and drive continuous improvement of QA processes.

The role includes audits, CAPA, batch records review, and regulatory compliance support under cGMP/ISO standards, with opportunities for growth

Qualifications

• Bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, Quality Management, or a related scientific discipline.

Responsibilities

• Ensure compliance with cGMP, ISO 9001, ICH Q7/Q10, and regulatory requirements.

Skills

Attention to detail

Analytical thinking

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in chemistry or related science

Tools

LIMS

MES

QMS software

Job description

Job Description

The Quality Assurance Engineer II is responsible for ensuring the quality, reliability, and performance of software products through systematic testing and quality practices. This role works closely with developers, product managers, and other stakeholders to design, execute, and improve test strategies while contributing to continuous improvement of QA processes. The QA Engineer II independently handles moderately complex testing efforts.

Primary Roles & Responsibilities

• Ensure compliance with cGMP, ISO 9001, ICH Q7/Q10, and relevant FDA/EMA regulatory requirements.
• Support development, review, and revision of SOPs, work instructions, and batch records.
• Lead customer complaints process.
• Perform QA review and approval of manufacturing documentation, including batch production records, logbooks, change controls, and deviations.
• Support internal and external audits; facilitate corrective and preventive actions (CAPA).
• Evaluate production processes for compliance, robustness, and consistency.
• Participate in process risk assessments (FMEA, HACCP, HAZOP).
• Support equipment qualification and facility validation activities (IQ/OQ/PQ).
• Review and verify analytical data, lab test results, or in‑process quality checks.
• Ensure raw materials and finished products meet specifications.
• Lead or support investigations of deviations, nonconformities, and OOS/OOT results.
• Perform root-cause analyses and identify corrective/preventive actions.
• Collaborate with cross‑functional teams (Manufacturing, Engineering, QC, Validation, etc.).
• Identify opportunities to improve quality performance, reduce cycle time, or enhance process control.
• Participate in Lean, Six Sigma, or operational excellence initiatives.
• Contribute to quality metrics reporting and trend analysis.
• Provide training and technical guidance on quality procedures, compliance expectations, and good documentation practices.
• Assist in onboarding and mentoring new team members.
• Interface with Internal and External Customers, Suppliers and Regulatory Agencies.

Qualifications

• Bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, Quality Management, or a related scientific discipline.
• 3+ years of experience in Quality Assurance within pharmaceutical, biotechnology, chemical manufacturing, medical devices, or GMP-regulated environments.
• Working knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
• Experience with FDA, EMA, ICH, OSHA, EPA, ISO 9001, and/or ISO 13485 standards.
• Experience participating in regulatory inspections and customer audits.
• Working knowledge of equipment qualification and process validation.
• Familiarity with LIMS, MES, or QMS software platforms.

We Value

• High attention to detail and strong quality mindset
• Ability to work independently and manage priorities
• Effective communicate/collaborate across cross‑functional teams
• Strong technical writing and documentation accuracy
• Analytical thinker with continuous improvement focus
• Oversee daily operational responsibilities.
• Maintain required documentation and reporting.
• Support continuous improvement initiatives.

Compensation

The annual base salary range for this position is $84,775K - $105,940K. Please note that this salary information serves as a general guideline. Solstice Advanced Materials considers various factors when extending an offer, including but not limited to the scope and responsibilities or the position, the candidate's work experience, education and training, key skills, as well as market and business considerations.

Benefits Of Working For Solstice Advanced Materials

• employer‑subsidized Medical, Dental, Vision, and Life Insurance
• Short‑Term and Long‑Term Disability
• 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance
• Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave)
• 12 Paid Holidays

Solstice Advanced Materials is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

About Us

About Solstice Advanced Materials

About Solstice Advanced Materials

Solstice Advanced Materials is a leading global specialty materials company that advances science for smarter outcomes. Solstice offers high-performance solutions that enable critical industries and applications, including refrigerants, semiconductor manufacturing, data center cooling, nuclear power, protective fibers, healthcare packaging and more. Solstice is recognized for developing next-generation materials through some of the industry's most renowned brands such as Solstice®, Genetron®, Aclar®, Spectra®, Fluka™, and Hydranal™. Partnering with over 3,000 customers across more than 120 countries and territories and supported by a robust portfolio of over 5,700 patents, Solstice’s approximately 4,000 employees worldwide drive innovation in materials science. For more information, visit Advanced Materials.