Job#: 2077188

Job Description:

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 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.
• Manage and perform training on Quality Management Systems
• Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
• Audit 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 as an owner, SME, and/or QA.
• Facilitate change control meetings.
• Apply discretion in decision-making.
• Demonstrate independent judgment and make recommendations regarding business practices.
• Create, implement, and interpret policies and operating practices.
• Communicate effectively with others.
• Perform work onsite.

This is what you need:

• Bachelor’s degree, preferably in a science field (chemistry, biology, engineering, etc.). An additional 8 years of experience could potentially be substituted for a BS degree - or similar education/work combination.
• Minimum 3 years’ experience in a Food and Drug Administration (FDA) regulated manufacturing environment.
• 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.
• American Society for Quality certifications.
• FDA & OSHA trained and familiar with current regulations.
• Project management and technical software skills (Excel, Access, etc.).
• Experience with FDA or other GMP audits.

EEO Employer

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. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join 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 ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: 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. 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, 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. 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 Apex team member can provide.