Quality Assurance Specialist II

Quality Assurance Specialist IIJob#: 3048310Job Description:Quality Assurance Specialist IIJob SummaryThe 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:Applicable to all levels of positionSupport 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 experienceMinimum 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 plusEverforth 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.Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Everforth Apex Benefits Overview: 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.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.If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.