Quality Assurance Specialist II

Apex Systems; Phoenix, Northern (AZ, KY); Hybrid; USD 65,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401K with company match

HSA and EAP

ESPP and discounts

Job summary

Everforth Apex seeks a Quality Assurance Specialist II to uphold and improve QA systems in a regulated manufacturing setting. On-site, Monday–Friday, you will manage documentation, audits, and training while supporting continual improvement across divisions.

The ideal candidate has a science background and at least 3 years in FDA-regulated manufacturing, with strong writing, organization, and communication skills to handle multiple projects independently.

Qualifications

• Minimum 3 years’ experience in an FDA-regulated manufacturing environment.
• Minimum 1-year experience training in a business setting.
• Minimum 3 years of progressive experience in Quality Assurance.
• Demonstrable strong written and verbal communication skills.
• Excellent organizational skills and documentation record.
• Ability to prioritize workloads and work under pressure.

Responsibilities

• Support QA infrastructure by documenting processes and SOPs.
• Perform GMP compliance tasks, audits, and documentation maintenance.
• Conduct internal supplemental audits to verify SOP and GMP alignment.
• Train and manage the QA Training Program.
• Maintain QA documentation systems and audit records.
• Interface with divisions to drive continual improvement and problem resolution.

Skills

FDA-regulated manufacturing

Documentation skills

Written & verbal comms

Organizational skills

Problem-solving

Risk assessment

Team collaboration

English proficiency

Education

BS/AAS in Chemistry or physical/biological science

Tools

Excel

Access

Job description

Quality Assurance Specialist II Job Summary

The Quality Assurance Specialist is responsible for performing Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems. This position will work onsite, Monday - Friday from approximately 6:30 am - 3:00 pm.

This is what you will do:

• Support the Quality System infrastructure by performing QA tasks pertaining to the documentation of processes.
• Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
• Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
• Perform training and manage the Quality System’s Training Program.
• Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
• Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
• Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
• Make changes to SOPs, policies, training materials, and other documents in the records management system.
• Assist during regulatory inspections.
• Interface with various Divisions in problem resolution, and continual improvement.
• Support manufacturing failure investigations and define investigational strategy.
• Facilitate meetings.
• Apply discretion in decision-making.
• Demonstrate independent judgment and make recommendations regarding business practices.
• Formulate, implement, interpret, and affect policies and operating practices.
• Communicate effectively with others.
• Perform work onsite.
• Perform other duties as assigned.
• Perform at an experienced and functional level therefore requiring limited supervision.
• Engage in Professional Development Activities.

This is what you will need:

• BS/AAS degree desired, preferably in Chemistry or in physical or biological science - or equivalent industry experience
• Minimum 3 years’ experience in a Food and Drug Administration (FDA) regulated manufacturing environment.
• Minimum 1-year experience training in a business setting.
• Minimum 3 years of progressive experience in Quality Assurance.
• Demonstratable strong written and verbal communication skills.
• Excellent organizational skills.
• Proven record of excellent documentation skills.
• Strong problem-solving skills.
• Work well under pressure and able to prioritize workloads.
• Ability to perform risk assessment.
• Experience fostering teamwork to get results.
• Well organized and multi-task oriented.
• Ability to work independently on multiple projects.
• Ability to read, write, and speak English competently.
• Ability to maintain reliable and predictable attendance.
• Worked in pharmaceutical, nutraceutical or similar mfg. environment (preferred).
• American Society for Quality certifications (preferred).
• FDA & OSHA trained and familiar with current regulations (preferred).
• Project management and technical software skills (Excel, Access, etc.) required.
• Project management experience (preferred).
• Experience training in safety, quality, and GMPs (preferred).
• Spanish speaking ability is a plus

About Everforth Apex

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Benefits

• Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection.
• We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure.
• Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
• In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
• Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach.
• You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Equal Opportunity Employer

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.