Certified Group

Ensure compliance with FDA regulations through managing eQMS, conducting audits, investigations, and maintaining documentation. | Bachelor's in a scientific or technical field, 3-5 years in FDA-regulated QA, experience with eQMS, investigations, and audits. | Certified Group partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. We are seeking a highly skilled Quality Assurance Specialist to join our team! In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance. Responsibilities • Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations. • Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks. • Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements. • Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed. • Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation. • Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, equipment maintenance records in accordance with FDA regulations. • Verify that all laboratory instruments and equipment are calibrated and maintained according to established schedules and regulatory standards to ensure accuracy and compliance. Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations. • Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems and proactively implement necessary changes to ensure compliance. Requirements • Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline. • 3-5 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology. • Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines. • Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms. • Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events. • Experience in conducting Internal Audits and familiarity with audit processes and methodologies. • Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization. • Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement. • Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment. Benefits • Progressive 401k Retirement Savings Plan • Employer Paid Short- Term and Long-Term Disability, and Life Insurance • Group Medical • Tuition Reimbursement • Flexible Spending Accounts • Dental • Paid Holidays and Time Off • Many positions which qualify for the company bonus program Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

Receive, prepare, and process customer samples for laboratory testing while maintaining proper documentation and safety protocols. | High school diploma or GED, basic knowledge or training in laboratory practices, and preferably one year of experience in a commercial food-testing laboratory. | Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.  We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team — including believing in you. We are currently looking for a Shipping & Receiving Technician to join our growing team! Job Summary Process customer samples ensuring protocols are followed for receipt and handling. Properly notify customers of issues related to samples submitted for testing. Essential Responsibilities • Receive, prepare, and set-up samples for analysis • Enter data, choose analyses, log and approve samples using a LIMS database on a Windows computer workstation • Process and maintain client samples at correct temperatures • Segregate samples according to FSNS procedures • Assist with shipping of customer supplies including return coolers to customers • Communicate with clients for clarification on orders as needed • Follow assigned series of processes, procedures and/or techniques in accordance with FSNS policies/procedures and customer requirements • Maintain laboratory conditions including equipment, supplies, quality assurance programs and accurate records throughout all procedures • Perform all activities in a neat, safe, hygienic, and efficient manner • Share information in an open, timely manner, maintaining customer satisfaction • Assisting with managing priorities and schedule such that individual goals as well as team goals are achieved with encouraged participation in the Food Safety Net Services Team • Responsible for the safety of oneself and others working within their area • Responsible for the completion of required training Minimum Qualifications • High School Diploma or GED • Basic knowledge of concepts and practices of a testing laboratory • Training in general laboratory practices preferred • One or more years of experience in a commercial food-testing laboratory preferred • Training in general laboratory practices • Or equivalent combination of education and experience PHYSICAL DEMANDS • Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components • Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens • Noise level varies from quiet to loud • Temperature varies from hot to cold • Interactive and fast-paced team-oriented tasks • Overnight Travel is required at the discretion of management • Occasionally lift and/or move up to 25 pounds. • Color vision and depth perception Benefits • Progressive 401k Retirement Savings Plan • Employer Paid Short- Term and Long-Term Disability, and Life Insurance • Group Medical • Tuition Reimbursement • Flexible Spending Accounts • Dental • Paid Holidays and Time Off Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran sta tus. Tuesday to Saturday 9am-6pm