Quality assurance auditor jobs near me

Quality Supervisor - Automotive Industry Columbus, OH $85,000 - $95,000 Bonus and excellent benefits Are you a visionary leader with a passion for driving excellence and innovation? We're on the lookout for a dynamic Quality Engineering Leader to lead and inspire a talented team within our esteemed automotive corporation. Join a company with a rich history of producing exceptional products and an unwavering commitment to continuous improvement. With a solid customer base and a forward-thinking culture, we're primed for long-term success. Enjoy an exciting career with outstanding benefits, job security, and the opportunity to make a lasting impact! Why You'll Love It Here:Comprehensive Benefits Package Job Stability: Join a company with a proven track record and a strong reputation Growth Potential: Lead, develop, and make strategic changes that will shape the future Key Responsibilities:Lead and Develop: Inspire and guide a talented quality team to reach new heights Manage: Supplier quality programs and processes for new model launch Enhance Quality Systems: Drive the implementation and continuous improvement of quality systems Improve Process Controls: Identify and optimize key processes to maintain top-tier standards Engage on the Shop Floor: Be hands-on in resolving quality issues and driving improvements Supervise Operations: Oversee staffing, training, and daily operations within the quality department Customer Collaboration: Work directly with customers to address issues and drive solutions Cross-Department Liaison: Collaborate with various plant departments to ensure seamless operations What We're Looking For:Proven leadership skills to inspire and drive teams to success Expertise in PPAP, APQP, FMEA, and root cause analysis Knowledge of IATF and TS16949 standards Bachelor's degree in a relevant field, automotive experience, and a strong, stable work history Previous experience in a quality engineering or supervisory role within an automotive manufacturing environment Excellent communication and organizational abilities Apply Today: Send your resume to ****************** or call us at ************. All inquiries are kept confidential. Omni One specializes in placing Engineers and Technical Professionals. Our services are employer-paid (at no cost to you).

We are seeking a detail-oriented and motivated professional to join our team at a leading global automotive company. This role plays a critical part in ensuring accurate and timely delivery of design changes and manufacturing instructions across multiple departments, supporting world-class vehicle production and innovation. The Regional Specification Control Coordinator supports Regional Spec Control by managing the delivery of Design Changes and Manufacturing Instructions to downstream units and departments. This role requires close collaboration with internal teams to ensure accuracy, completeness, and on-time delivery aligned with project milestones and purchase order requirements. Key Responsibilities Support Regional Spec Control with the delivery of Design Changes and Manufacturing Instructions to downstream units and departments Collaborate closely with internal teams to ensure timely and accurate communication of updates Review work lists daily and prioritize delivery of Design Changes and Manufacturing Instructions using dashboards and direction from Group Leaders and New Model Project Leaders Deliver Design Changes to LSC with a high level of detail and accuracy Review, correct, and resubmit Manufacturing Instructions when incomplete or not ready for release Deliver Manufacturing Instructions to LSC with accuracy and attention to detail Coordinate with teams and units to ensure all required items are delivered prior to purchase orders Actively participate in team meetings and provide support to team members as needed Required Skills and Qualifications Minimum of 5+ years of on-the-job experience Completion of a vocational training program may substitute for 1 year of experience High School Diploma or GED required Excellent communication skills to effectively work with Spec Control associates and external departments regarding Design Changes and Manufacturing Instructions Proficiency in Microsoft platforms and SharePoint Ability to quickly learn new systems, including BOM delivery systems such as DCMS and BEAM Previous experience communicating and interfacing with stakeholders and leadership members/teams. Location: Raymond, OH (4 days onsite, 1 day remote) Submit resumes to ***********************

About the Role Whisker Labs is seeking a Manager of Quality Assurance to join our fully remote development team. Our mobile apps, web portals, APIs, backend components, and AI models play a critical role detecting early warning signs of electrical fires in homes, preventing one of the deadliest types of fires. Our products are used by over 1 million customers to help detect and mitigate fire hazards in homes, quite literally saving lives. Whisker Labs is growing rapidly, and the team maintains a high-energy, fast moving, and creative culture. The candidate will work within software development scrum teams and the quality assurance team to improve our quality assurance processes and tooling, understand functional requirements, define test cases, implement automated test suites for UIs and APIs, and execute and document those test suites. You must have substantial experience as a quality assurance engineer, as a leader of quality assurance teams, and be able to implement automated test cases in one or more UI test automation frameworks and API test automation frameworks such as Postman, Playwright, Cypress, TestComplete, JMeter, or similar. Key Responsibilities Lead Quality Assurance team, improving and establishing quality assurance processes and tooling. Mentor and manage quality assurance team members. Perform regular performance reviews and 1 on 1s. Fulfill a functional lead role in quality assurance testing of complex web portals and APIs. Fulfill a functional lead role in quality assurance testing of complex web portals and APIs. Collaborate with scrum team and product to define and document test cases. Implement and execute automated test suites for web portals and APIs using frameworks and such as Cypress, Playwright, Postman, and others. Implement and automate test suites using languages such as JavaScript and .Net C#. Utilize Jira and participate in daily scrum team “standups” to communicate and manage testing stories and testing activities. Utilize test case documentation tools such as TestRail to document test suites as well as the results of running those test suites. Thorough functional and cross browser testing of web portals. Understanding of our wider software solution, collaborating with peers across teams. Establish and maintain a high level of productivity and agility within a scrum team of high skilled full stack developers and data scientists. Qualifications Minimum of 3 years experience as a leader of a quality assurance organization, with personnel management responsibility. Minimum of 7 years experience as a highly productive and hands on quality assurance tester. Strong proficiency in one or more UI test automation frameworks such as Cypress, Playwright, TestComplete, or others. Proficiency implementing automated test suites in JavaScript and/or .Net C#. Strong proficiency in one or more API test automation frameworks such as Postman, NUnit. Minimum 5 years of hands-on experience implementing automated test suites. Extensive experience defining, documenting, and executing manual test cases for web portals and APIs. Experience with cloud ecosystems such as AWS. Bachelor's degree in computer science or computer engineering, or equivalent professional experience. Extensive experience with Jira. Extensive experience working within an agile scrum team. Experience with Git or equivalent code management tool. Ability to work effectively and reliably in a fully remote, fast-paced environment. Independent, self-learner, excellent problem solver. Preferred Qualifications Experience integrating automated tests suites with GitHub and build pipelines. Experience with TestRail. Experience with mobile app testing. Why Join Us? By joining our team, you will have the opportunity to be a part of a groundbreaking technology that is creating a new category while helping to protect families, homes, and communities from the devastating impacts of electrical fires. We are a passionate team, dedicated to revolutionizing fire prevention to make the world a safer place. Our pace and growth trajectory offer exceptional opportunities for professional development, and we offer competitive compensation and comprehensive benefits. If you want to take ownership, shape strategy, and drive meaningful change, you'll love Whisker Labs. Whisker Labs is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Lead Auditor will play a critical role in ensuring the adequate implementation of the Structural Integrity Associates quality assurance program. The individual in this position will be expected to provide quality engineering support, perform surveillances, and lead and support internal and supplier quality assurance audits. As such, the individual should be able to qualify as a lead auditor under the Structural Integrity Associates quality assurance program within the first six months of hiring on with the company. The position will also involve the performance of contract review and approval, review to support project closeout, and support of the corrective action program. Primary Responsibilities: Plan and conduct comprehensive NQA-1 audits of nuclear processes to verify compliance with regulations, standards, and implementing procedures Perform surveillances to monitor compliance with quality assurance standards Follow-up on audit findings to ensure effective implementation of corrective actions Liaise with organizational stakeholders to manage the corrective action process Contribute to the development and improvement of quality program and procedures Maintain certification as Lead Auditor in accordance with NQA-1 Review project packages against requirements in support of contract review and project closeout Review calibration records to support project activities Update approved suppliers list, performing annual and triennial updates, as applicable, to maintain associated supplier information Knowledge, Skills, and Abilities: Extensive experience with 10 CFR 50, Appendix B and NQA-1 Experience with the implementation of 10 CFR Part 21 is desired Knowledge of commercial grade dedication Familiarity with quality assurance program development, maintenance, and implementation is desired Experience in an operating quality assurance organization is highly desired Skilled in leading NIAC or NUPIC audits is highly desired Experience with customer audits is desired Knowledge in the performance of quality control inspections is desired Problem solving, critical thinking, self-starter, with effective written and verbal communication Minimum Qualifications: Bachelor's degree and five years of nuclear experience, or Associate's degree and seven years of nuclear experience. At least five years of experience in leading nuclear quality assurance audits is desired. Work Environment: The position can be performed remotely, with at least 25% travel to perform audits and support customer audits as needed If remote, the individual must be able to follow the remote work policies Pay Range: The expected salary range for this role in North Carolina is $117,000 - $125,000 annually. Exact pay will be commensurate with experience. Export Control Notice: Certain positions at SIA may require access to information and technology which is subject to Export Administration Regulations 15 CFR 730-774, including those of the US Department of Energy (DOE) in 10 CFR 810 and Nuclear Regulatory Commission (NRC) 10 CFR Part 110. Hiring decisions for such positions must comply with these regulations and may result in SIA limiting its consideration of foreign nationals who are citizens of countries that are not on the DOE's Generally Authorized Destinations List: *************************************************************************************************** About Us: SIA is an engineering consulting firm serving various industries including Nuclear Power, Energy Services, Pipeline Integrity, and Critical Infrastructure. Join a team of internationally recognized experts in a culture based on knowledge, excellence, and respect for one another. Our employees are members of a distinct community of internationally respected professionals committed to quality, engineering innovation and a shared goal of building a safer world. Why Work at SIA? SIA offers a competitive salary and performance-based bonus program. Our retirement benefits include a Traditional 401k, Roth 401k, and an employer match. To help employees maintain a work-life balance, SIA also offers various paid time off including vacation, floating holidays, sick time, and parental leave. Our employees also enjoy a comprehensive benefits program that includes the following: Medical, dental, and vision insurance Life Insurance and AD&D Short-term and long-term disability Health Savings Account with employer contribution Flexible Spending Account for health care and dependent care ID theft protection and credit monitoring Structural Integrity Associates, Inc. is an equal opportunity employer. ***************** SIA does not welcome third-party recruiters, employment agencies, headhunters, etc. Please do not reach out to SIA employees requesting a call, sit down, meeting, or email response.

is 100% Remote.** **Scope of Responsibilities:** + Conduct moderately complex to complex quality audits of provider claims, pre-payments and post-payments including high-dollar and specialized claims across multiple lines of business, claim types and products. + Audit the work of more junior auditors and identify opportunities for coaching and//or training. + Identify and communicate issues identified through audits and recommended solutions relevant to business operations. + Assist management in preparing departmental reports policies and procedures. + Mentor and coach Financial and//or Operations QA auditors. + Participate as a Subject Matter Expert on various process improvement projects designed to meet departmental and operational needs. + Assist with performing User Acceptance Testing (UAT) on system enhancements or corporate projects in partnership with Business Operations + Analyze errors and determine root causes for appropriate classification. + Record//track quality assessment scores and provide feedback to reduce errors and improve processes and performance to ensure the quality of the network. + Review and investigate claims and encounters for medical, facility, pharmacy, dental and vision services including contractual provisions, authorizations and Healthfirst policy and procedure. + Prepare written reports concerning investigation activities and present results of investigations to senior staff. + Complete subsequent auditing and handling of specific claims and appeal requests including processing where applicable, tracking, documenting, reporting and dispersal of findings and recommendations. + Review the accuracy and efficiency of existing training materials. **Minimum Qualifications:** + Audit experience with the investigation, determination and reporting of financial processes + Work experience in Microsoft Office suite of applications including advanced Excel (formatting formulas, managing data, filtering results), Word (creating and editing documents), PowerPoint (creating and editing presentations) + Experience conducting root cause analysis in an auditing capacity + Experience conducting analytical work and providing creative ideas for problem solving + Work experience requires written and verbal communication that is clear, concise, grammatically correct, and professional + Experience handling confidential information + Associate degree from an accredited institution **Preferred Qualifications:** + Bachelors degree from an accredited institution + Audit experience with the investigation, determination and reporting of financial processes _specifically around Healthcare Claims Adjudication and Claims Processing_ + Ability and willingness to handle increasing workload and responsibility + Willingness and ability to learn and evaluate new information, both technical and procedural + ICD10 certification + Basic foundation of SQL, Tableau, and SharePoint + Knowledge of at least two or more lines of business such as NY Medicare, Medicaid, Family Health Plus, Child Health Plus WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, gender identity, sexual orientation, national origin, age, genetic information, military or veteran status, marital status, mental or physical disability or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Are you passionate about making a difference in people's lives? Do you enjoy working in a service-oriented industry? If so, this opportunity may be the right fit for you! This position is responsible for proactive Clinical Quality Auditor to support the ongoing monitoring and evaluation of call quality, ensuring compliance with industry regulations, and enhancing the overall customer experience. In addition to auditing calls and processes, this role will also be responsible for processing clinical escalations and assisting with resolving any related issues. This role… Audit Strategy & Implementation: Implements audit strategies to assess the quality of calls, compliance with healthcare regulations, and overall adherence to quality standards. Conduct audits on calls, clinical charts, processes, procedures, and systems to ensure adherence to industry standards. Escalations: Process and respond to unresolved escalations (issues that arise in calls that are unable to be resolved in the moment), working closely with relevant teams to address issues and provide timely resolutions. Clinical Escalations: Complete reviews of clinical escalations resulting from outlier biometrics for process and quality recommendations. Audit Reporting & Communication: Communicates audit findings, analysis, and recommendations to senior management and key stakeholders. Highlight trends, actionable insights, and areas requiring improvement. Corrective Action Planning: Collaborates with internal teams to identify action plans and implement corrective actions based on audit findings. Tracks and monitors the progress of these action plans. Team Development & Coaching: Provides coaching and development to team members on job skills, delivery skills, and quality improvement. Offers targeted support for individuals needing additional coaching on soft skills or specific job tasks to enhance team performance. Compliance Monitoring: Ensures ongoing compliance with quality standards, industry regulations, and internal policies by extracting and evaluating calls. Monitors and assists in meeting compliance and productivity goals. Trend Analysis & Reporting: Analyze call data to identify trends, gaps, and areas for improvement. Prepare reports to share with senior management for decision-making purposes. Communication with Stakeholders: Build and maintain strong relationships with internal and external stakeholders, including healthcare providers, patients, and regulatory agencies. Ensure clear communication of audit results and next steps to involved parties. Handles routine inquiries and relay information between departments and stakeholders. Maintains security and access to sensitive materials. Assists with maintaining productivity and quality goals. Monitors and assists with QA chat channels to provide real-time support. Performs other duties as assigned by management. We are interested in speaking to individuals with the following… Bachelor's Degree in health related field required. Five (5) plus years of clinical experience. Current and unobstructed RN licensure (Preferred) Or equivalent combination of education and/or experience. Strong attention to detail and organizational skills. Collaborative and team-oriented approach. Ability to handle sensitive and confidential information. Problem-solving mindset and proactive in addressing challenges. Adaptable and flexible in responding to changing business needs. Strong knowledge of industry regulations, compliance standards, and audit processes. Excellent analytical skills with the ability to identify trends and provide actionable insights. Strong communication skills, both written and verbal, with the ability to report findings and collaborate with various departments. Experience in coaching and training team members to improve performance and achieve quality goals. Ability to work independently, prioritize tasks, and manage multiple projects simultaneously. Familiarity with clinical processes and the handling of clinical escalations is a plus. Proficiency in quality assurance software, data analysis tools, and Microsoft Office Suite (Excel, Word, PowerPoint). Salary: $60,800.00 - 82,100.00 / annually Modivcare's positions are posted and open for applications for a minimum of 5 days. Positions may be posted for a maximum of 45 days dependent on the type of role, the number of roles, and the number of applications received. We encourage our prospective candidates to submit their application(s) expediently so as not to miss out on our opportunities. We frequently post new opportunities and encourage prospective candidates to check back often for new postings. We value our team members and realize the importance of benefits for you and your family. Modivcare offers a comprehensive benefits package to include the following: Medical, Dental, and Vision insurance Employer Paid Basic Life Insurance and AD&D Voluntary Life Insurance (Employee/Spouse/Child) Health Care and Dependent Care Flexible Spending Accounts Pre-Tax and Post --Tax Commuter and Parking Benefits 401(k) Retirement Savings Plan with Company Match Paid Time Off Paid Parental Leave Short-Term and Long-Term Disability Tuition Reimbursement Employee Discounts (retail, hotel, food, restaurants, car rental and much more!) Modivcare is an Equal Opportunity Employer. EEO is The Law - click here for more information Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled We consider all applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, handicap or disability, or status as a Vietnam-era or special disabled veteran in accordance with federal law. If you need assistance, please reach out to us at ***************************

Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Columbus Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

The Quality Assurance (QA) Auditor provides compliance and quality improvement support for the manufacture of phase 1/2a Investigational New Drug, Biologics manufacturing, and facility operations. This role works alongside the Quality Assurance Manager to plan, schedule, and conduct audits as well as administrative tasks to support the quality management program. The QA Auditor ensures the biologics manufacture and facility adhere to applicable regulations, policies, procedures, and expectations of phase-appropriate current Good Manufacturing Practices (cGMP). Additionally, the QA Auditor participates in various quality and process improvement initiatives as directed by the Quality Assurance Manager. Responsibilities * Operate within the Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices. * Maintain current knowledge of applicable phase-appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices. * Lead data review processes to facilitate biologic IND product release. * Perform GMP and Good Documentation Practices training for manufacturing and support personnel. * Lead QA functions related to Quality programs such as process, laboratory audits, protocol approvals, etc., as assigned. * Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits. * Support the QA Manager in mentoring and training QA staff as needed. * Assist the QA Manager during client and regulatory audits, and in client audits for records review. * Manage, review, and approve controlled documents necessary for effective functioning of biologics manufacture and good tissue practices. * Provide additional support to the Quality Assurance Manager as required. Essential Skills * Bachelor's degree in a scientific discipline with a minimum of 3 years of quality or regulatory experience. * Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP). * Proficient computer skills, including Microsoft Office Suite, SharePoint, and Quality Management Systems. * Experience in conducting audits and technical writing. * Ability to guide and train QA staff in various tasks. * Willingness to travel for vendor/supplier audits and trainings (approximately 15%). * Strong interpersonal, organizational, and leadership skills. * Ability to manage multiple tasks simultaneously in a growing department. Additional Skills & Qualifications * Prior experience in technical writing is preferred. Work Environment The culture is very team-oriented, with a diverse group of individuals continuing to grow. The team currently comprises around 4 individuals, working in collaboration with other teams totaling approximately 23 people, with plans to expand further by the end of the year. Collaboration is essential as no work or testing is conducted alone. Work hours are 1st shift, Monday to Friday, 8:00 AM to 4:30 PM, with occasional overtime. Job Type & Location This is a Contract to Hire position based out of Columbus, OH. Pay and Benefits The pay range for this position is $28.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Columbus,OH. Application Deadline This position is anticipated to close on Jan 11, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The Electrical Cx - QA/QC Support Specialist ensures that electrical systems in data center projects meet all quality, safety, and operational requirements. This role combines proactive oversight with responsive problem-solving to ensure that power distribution, grounding, and protection systems are properly designed, installed, tested, and commissioned according to owner expectations, safety standards, and industry best practices. Due to the hazards associated with electrical systems, the specialist supports and coordinates closely with the Energy Marshal, confirming all pre-energization verifications and documentation are complete before startup. Working collaboratively with contractors, engineers, and customer teams, the specialist maintains professionalism under pressure and encourages a cooperative, improvement-oriented culture. The ideal candidate brings deep experience in electrical commissioning, strong safety awareness, and excellent communication and analytical skills. Location: This position is considered remote work, but you are required to be on-site at various client project sites each week as assigned. Key Responsibilities: Commissioning Activities Ensure all electrical systems are installed, tested, and performing in accordance with project specifications, design intent, and applicable codes and standards. Review Factory Acceptance Test (FAT) results for major equipment and track closure of open or deferred items with vendors and site teams prior to functional testing. Conduct proactive inspections through L1-L3 phases to confirm proper handling, installation, and readiness of equipment such as switchgear, PDUs, UPS systems, transformers, and generators. Verify that pre-functional and startup testing (L3) are properly executed and documented by trade contractors, ensuring all Lockout/Tagout (LOTO) and energization activities are coordinated with the site Energy Marshal. Validate integration between electrical, mechanical, and control systems, and oversee corrective actions through retesting prior to handoff to commissioning. Documentation and Reporting Prepare, maintain, and track QA/QC documentation-including inspection reports, checklists, MOPs, and test verification forms-within approved customer platforms. Compile and submit comprehensive commissioning reports and turnover packages that include test results, lessons learned, and as-built documentation. Collaboration and Communication Coordinate daily with project managers, design engineers, contractors, and client representatives to align quality and commissioning activities with project milestones. Participate in commissioning meetings, site walkdowns, and coordination sessions to report progress and identify potential risks or delays. Communicate findings constructively and participate in coordination meetings to report QA/QC progress, readiness, and safety verification prior to energization. Quality Assurance Perform field inspections to verify conformance with drawings, specifications, and best practices, emphasizing electrical safety and energization readiness. Identify and document non-conformances, recommend corrective actions, and support procedural improvements to enhance safety, efficiency, and reliability. System Turnover & Handoff Support Support commissioning handoff from L3 to L4, coordinating documentation and verifying closeout deliverables. Collect and verify O&M manuals, training materials, warranties, and attic stock for turnover to operations. Assist in scheduling and pre-coordination of training for operations staff. Qualifications: Education: Bachelor's degree in Electrical Engineering or a related field. Equivalent experience may be considered. Relevant certifications, such as Certified Commissioning Professional (CCP), Professional Engineer (PE), or LEED Accredited Professional, are a plus. Experience: Minimum of 5 years of experience in electrical systems commissioning, preferably in data centers or mission-critical facilities. Expertise in electrical distribution systems, including low, medium, and high-voltage equipment. Familiarity with industry standards and codes, such as IEEE, NEC, NFPA, and NETA. Skills: Strong technical knowledge of electrical system design, operation, and testing. Proficient in commissioning and project management software, such as Cx Alloy, Bluebeam, Procore, or similar platforms. Excellent problem-solving and analytical skills. Strong verbal and written communication skills. Ability to manage multiple priorities in a dynamic, fast-paced environment. Working Conditions: Regular travel to data center project sites. Ability to work in construction and industrial environments, including exposure to varying temperatures, noise levels, and confined spaces. May require extended hours during critical project phases. Compensation: $80,000 - $130,000, dependent on experience and location Health Benefits: Medical, Dental, Vision, LTD/STD, Life-AD&D Retirement: 401(k), discretionary Pension & Profit sharing, subject to Plan documents 15 days paid time off (prorated based on start date) and 8 holidays About Vertex Vertex Innovations, Inc. is a Colorado company founded in 2003 by Wayne and Erica Smith. "We could see where the future of communications was heading and wanted to take our passion and skill to build the nation's telecommunications infrastructure." Since those early days, Vertex Innovations has managed the buildout of today's wireless and fiber networks connecting millions of Americans and improving their daily lives. Our mission is to utilize our talents, experience, knowledge, and determination to create a connected society where everyone has the opportunity to foster meaningful connections, acquire knowledge, and make a positive impact on society. At Vertex, these Core Values created by our team serve as our guide in shaping today's connected society. Integrity - To move through the world with honesty and truth empowering our employees, clients and communities through our words and actions. Accountability - To take full ownership and responsibility in our roles as we serve our company, clients and communities. Commitment - To stand behind our word and our promises Respect - To embrace and honor the individuals, clients, and companies in their contribution to the work that we create together through our interactions, conversations and our way of being. Performance - To allow ourselves to be measured by our commitments and be accountable for every action to our employees, clients, and communities. VERTEX Innovations, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

US Fertility, the nation's largest partnership of physician-owned and physician-led top-tier fertility practices, a national network of premier IVF laboratories, are united under a shared mission to deliver the joy of parenthood through advanced reproductive medicine and innovative science. The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB). We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed. How You'll Contribute: Implement, monitor, maintain, and improve the company's Quality System Implement, monitor, and maintain a document control system Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed Assure appropriate licensure is held and maintained by the company Facilitate quarterly meetings with medical directors to provide regulatory and quality updates Ensure medical directors complete all signoffs as required Assure compliance to international regulatory agencies Tracking and trending of laboratory, cryogenic, andrology, and deviation systems Maintain and improve deviation/non-conformance system Report events to regulatory bodies as applicable Assure training and competency of all staff Assist in preparation of regulatory strategies for changes to existing systems Participate in Continuing Education programs in related field Participate in planning and implementation of regulatory systems, document/change control and validation activities Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies Implement and oversee audits for departments and systems to assure compliance to regulations and standards Track and ensure any identified deficiencies are rectified post an inspection/audit event Monthly and quarterly in person audits of quality and regulatory manuals and records Monthly and quarterly reports to leadership on Quality and Regulatory activities Perform other related duties as assigned by management What You'll Bring: Bachelor's degree or equivalent combination of training and experience Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy Must be able to interact and communicate professionally with individuals at all levels of the organization Clear and effective communication skills Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint) Self-starter that adapts well to change in a fast-paced, dynamic environment Prior laboratory experience preferred Knowledge of industry, Federal and State regulations, licensing processes Strong aptitude for analyzing data, audit processes and reconciling records Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships. Excellent verbal & written communication skills Ability to work as part of a multi-disciplinary team Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.) Occasional travel required (up to 25%) Able to adapt and thrive in the fast-paced, rapidly changing environment The successful candidate will have the ability to work well independently, as well as part of a team Excellent multi-tasking abilities More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful. What We Offer: Competitive pay + bonus Comprehensive training Medical, dental, vision, and 401(k) matching Generous paid time off and holidays Retirement plan Tuition assistance Ability to make an impact in the communities we serve At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team! To learn more about our company and culture, visit here.

Clinical Quality Assurance Specialist Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs. This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance. ESSENTIAL FUNCTIONS Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials. Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.) Complete required tasks in the electronic quality management system Assist with training coordination, ensuring employees are up to date on quality and compliance requirements Assist with audits of external suppliers Routinely work with internal and external stakeholders to achieve cross-functional goals. Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames. REQUIRED QUALIFICATIONS Education Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline EXPERIENCE 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry PREFERRED QUALIFICATIONS Knowledge of GMP and GCP regulations Strong attention to detail, documentation accuracy, and organizational skills Microsoft Office Experience with MasterControl is desirable Experience with CDER BIMO inspections is desirable COMPETENCIES Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization. Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences. Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders. Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues. Decision-Making/Judgment : Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures. WORK ENVIRONMENT This position can work remotely in the United States. TRAVEL EXPECTATION Up to 10% What you can expect as a Lumosian Industry-competitive compensation Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance. Lumos covers 85 - 95% of the medical premium Health Reimbursement Arrangement 8 weeks of fully paid parental leave for all new parents Gym or fitness class reimbursement 401(k) with 5% employer contribution Flexible work hours and location Generous PTO policy 11 paid holidays in the US Offices in Austin, TX, and Ames, IA

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra's solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The ASSURE Patient Specialist (APS) conducts patient fitting activities in support of the sales organization and the team of Regional Clinical Advisors (RCA). The APS will serve as the local patient care representative to provide effective and efficient patient fittings. This is a paid per fitting position. ESSENTIAL DUTIES Act as a contractor ASSURE Patient Specialist (APS) to fit and train local patients with a wearable defibrillator via training assignments dispatched from corporate headquarters. The APS will be trained and Certified as an ASSURE Patient Specialist by Kestra. Ability to provide instruction and instill confidence in Assure patients with demonstrated patient care skills Willingness to contact prescribers, caregivers and patients to schedule services Ability to accept an assignment that could include daytime, evening, and weekend hours Travel to hospitals, patient's homes and other healthcare facilities to provide fitting services Measure the patient to determine the correct garment size Review and transmit essential paperwork with the patient to receive the Assure garment and services Manage inventory of the Assure system kits, garments, and electronic equipment used in fittings Flexibility of work schedule and competitive pay provided Adhere to Pledge of Confidentiality Information regarding a patient of this company shall not be released to any source outside of this company without the signed permission of the patient. Furthermore, information will only be released internally on a need-to-know basis. All Team Members will not discuss patient cases outside the office or with anyone not employed by this company unless they are directly involved with the patient's case. COMPETENCIES Passion: Contagious excitement about the company - sense of urgency. Commitment to continuous improvement. Integrity: Commitment, accountability, and dedication to the highest ethical standards. Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service. Action/Results: High energy, decisive planning, timely execution. Innovation: Generation of new ideas from original thinking. Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind. Emotional Intelligence: Recognizes, understands, manages one's own emotions and is able to influence others. A critical skill for pressure situations. Highly organized, service and detail orientated Passionate about the heart-failure space and a strong desire to make a difference Strong interpersonal skills with communicating and assisting clinicians with providing care for patients. Interest and desire for life-long learning to continuously improve over time. Requirements Education/Experience Required: 1 year in a paid patient care experience (not as a family care giver) Clinical or engineering background which may include but is not limited to nurses, cardiac device sales representatives, clinical engineers, catheterization lab technicians, physician assistants, or ECG technicians. Disclosure of personal NPI number (if applicable) Completion of background check. Florida and Ohio must complete a level 2 screening paid for by Kestra. Willingness to pay an annual DME fee which is deducted from the completed work order Ability to pay for vendor credentialing upfront during a 90-day probationary period Experience in patient and/or clinician education Valid driver's license in state of residence with a good driving record Ability to consistently work remotely Disclosures are required for any potential relationships and referral sources Must be able to achieve credentialing for hospital system entry including, but not limited to: Documentation of vaccination and immunization status Pass background check Pass drug screening testing Review and agree to hospital policies and procedures Completion of online courses, i.e., HIPAA, Bloodborne Pathogens and Electrical/Fire Safety Preferred: Knowledge of MS Office, Excel, PowerPoint, MS Teams Direct cardiac patient care experience - RN, RT, CVIS, Paramedic, CRM WORK ENVIRONMENT Variable conditions during travel Minimal noise volume typical to an office or hospital environment Possible environmental exposure to infectious disease (hospital and clinic settings) Extended hours when needed Drug-free PHYSICAL DEMANDS Ability to travel by car Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage Frequent stationary position, often standing or sitting for prolonged periods of time Frequent computer use Frequent phone and other business machine use Occasional bending and stooping Ability to lift up to 40 pounds unassisted, at times from in and out of vehicle TRAVEL Frequent travel by car in agreed upon geography OTHER DUTIES: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Shape the Future of Clinical Accuracy. Are you a coding professional who thrives on precision, collaboration, and continuous improvement? As a QA Specialist, you'll play a key role in ensuring the integrity of clinical documentation and coding across both Inpatient and Outpatient settings. This is an opportunity to make a real impact-enhancing compliance, optimizing reimbursement, and supporting better patient outcomes. Position Summary: The QA Specialist is responsible for ensuring the accuracy, compliance, and integrity of coding and clinical documentation across Inpatient and Outpatient settings. This role will focus on auditing ICD-10-CM/PCS/CPT/HCPCS codes, and IRF-PAI submissions to validate adherence to regulatory requirements, payer guidelines, and organizational standards. The QA Specialist collaborates with coders, clinical teams, and leadership to identify trends, provide feedback, and implement process improvements that enhance coding accuracy, optimize reimbursement, and minimize compliance risk. Key Responsibilities: Audit Inpatient, Outpatient, and IRF-PAI coded records for accuracy, compliance, and completeness. Validate ICD-10, CPT, HCPCS, and IRF-PAI coding/documentation against guidelines and payer rules. Provide feedback and education to coders and clinicians on audit findings. Track and report audit results, error trends, and coder performance. Ensure compliance with CMS, OIG, HIPAA, and payer requirements. Collaborate with coding, CDI, and revenue cycle teams to improve documentation and coding practices. Support readiness for regulatory updates and external audits. Qualifications: CCS, CPC, CIC, or CCA certification; additional IRF-PAI training/certification preferred. 12 months in coding and/or auditing Inpatient, Outpatient, and/or Rehab records; strong knowledge of ICD-10-CM/PCS, CPT, and HCPCS coding systems. Strong knowledge of ICD-10-CM/PCS, CPT, HCPCS, DRGs, APCs, and IRF-PAI requirements. Excellent analytical, communication, and reporting skills proficiency with EHR and coding/auditing software. Netsmart is proud to be an equal opportunity workplace and is an affirmative action employer, providing equal employment and advancement opportunities to all individuals. We celebrate diversity and are committed to creating an inclusive environment for all associates. All employment decisions at Netsmart, including but not limited to recruiting, hiring, promotion and transfer, are based on performance, qualifications, abilities, education and experience. Netsmart does not discriminate in employment opportunities or practices based on race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, physical or mental disability, past or present military service, or any other status protected by the laws or regulations in the locations where we operate. Netsmart desires to provide a healthy and safe workplace and, as a government contractor, Netsmart is committed to maintaining a drug-free workplace in accordance with applicable federal law. Pursuant to Netsmart policy, all post-offer candidates are required to successfully complete a pre-employment background check, including a drug screen, which is provided at Netsmart's sole expense. In the event a candidate tests positive for a controlled substance, Netsmart will rescind the offer of employment unless the individual can provide proof of valid prescription to Netsmart's third party screening provider. If you are located in a state which grants you the right to receive information on salary range, pay scale, description of benefits or other compensation for this position, please use this form to request details which you may be legally entitled. All applicants for employment must be legally authorized to work in the United States. Netsmart does not provide work visa sponsorship for this position. Netsmart's Job Applicant Privacy Notice may be found here.

. As part of one our ongoing Oracle HCM implementation, we are looking for a QA / Testing expert who can work remotely and have had previous experience in 1. Oracle Payroll testing 2. Integration Testing 3. Any experience in OIC, Oracle Integration Cloud Services is a Plus. If interested, please rush your resume, with contact details and mention your absolute best rate/hr.

The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance with the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Support external audit activities (FDA, FDB, ISO registrar audits etc.). Audit areas of client s Vascular Quality System. Support administration of Quality System processes (CAPAs, Internal Audits etc.). Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. Assist the organization to receive timely feedback on open corrective actions. Participate in cross divisional activities to integrate quality system information. Conduct review and update Quality System procedures as necessary. Assist in developing & conducting Quality System training as necessary. File Quality Records (audit reports, IACAs, CAPAs etc.). Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned. Education: Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.

Join Our Team As part of our Cinemark Universe, you'll discover fun opportunities with real growth potential and plenty of perks. With 500+ theatres and nearly 6,000 screens; we're truly a global presence of 20,000 movie lovers working together to make unforgettable experiences. Role Summary: As a member of the Technology Operations Presentation (TOP) department, the Quality Assurance Specialist has the primary responsibility to maintain Cinemark presentation standards and ensure maximum uptime by resolving equipment issues and satisfying equipment maintenance requirements. The Quality Assurance Specialist works closely with the TOP Center to maintain uptime and Theater Technology Assistant (TTA) to provide training and ensure maintenance continuity. The position requires extensive travel, working during off-business hours, and on-call availability. Relocation may be required as the position must be based in a geographical area that best services the assigned territory. This position will be located in Dayton, Ohio. Responsiblities: Ensure on-screen presentations are up to Cinemark standards Ensure equipment is operating to Cinemark standards for projection and audio systems Perform routine preventative maintenance, repairs and emergency service on digital cinema and audio equipment Train TTA and management on operation and maintenance of projection and sound equipment Ensure all TOP Center directives are being implemented in theaters Respond to off screen emergency and service tickets assigned by the TOP Center Participate or assist with special projects, screenings, and events when needed Install projection and sound equipment for new theater openings and projects Communicate professionally with theaters and supervisors Complete all administrative duties by required deadlines Order parts when necessary to keep theaters compliant with Cinemark standards Requirement: A minimum of two years of experience in theatre projection and sound is desired Physical demands include climbing ladders, working in tight spaces and lifting 50+ pounds High school diploma or equivalent is required, any college or higher education a plus Attention to detail, quality-focused and strong problem-solving skills are important assets Strong written and verbal communication skills Proficient in Microsoft Office Barco certification in digital cinema is an asset Benefits Available: At Cinemark, we believe every team member should feel like a hero. Each career comes with a variety of blockbuster benefits for both hourly and salaried team members. Employee Discount 401(k) Matching* Growth Opportunities Education Assistance* Health Benefits* Parental Leave* Paid Time Off* Daily Pay* Free Movies* * Benefits may vary by career category, so be sure to check the specific details on our career site. DISCLAIMER: This is intended only as a general guideline of your duties and responsibilities at Cinemark and is not a legally binding contract. Cinemark reserves the right to amend, change or terminate the , as it deems appropriate. Any change amendments, or modifications may be implemented even though they have not been communicated, reprinted or substituted in this job description. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Cinemark is an Equal Opportunity Employer Pay Range: 27.01 - 33.77

Wojeski & Company is an Albany, New York based CPA mid-size Firm with an excellent reputation and a great culture. We are "accountants with personality" known for our expertise, high service standards, impeccable integrity, community involvement and fun! Our service-oriented firm provides audit, tax, and consulting services to a broad range of clients. Position Summary: The Audit Associate will be responsible for performing necessary procedures in attestation engagements for clients in accordance with applicable accounting standards. This position will assist audit senior associated and managers with tasks and assigned projects, and work with a diverse client base. The audit associate should be eager to develop the fundamental knowledge and technical skills to grow into a senior role within the firm. Responsibilities: Perform and assist with audits, reviews and compilations for clients in various industries. Prepare financial statements, reports and other required compliance information. Assist with the coordination of the planning, fieldwork and wrap-up of engagements. Develop effective working relationships with clients Communicate with managers and partners, keeping them apprised of project status Interaction with clients to help ensure that requests and information is received for the engagement Have initiative to learn and develop new audit and attest skills Maintain and promote the ideals, values, mission, and vision of Wojeski & Co. Qualifications: Bachelor's or Master's degree in accounting CPA candidate, if not already obtained 1+ years of public accounting auditing experience Strong computer skills Strong written and oral communication skills Ability to work addition hours during peak client service delivery times Benefits and Perks Include: Company Outings In-Office Events Competitive compensation and PTO 401(k) program with employer match Discounted Financial Planning/Counseling Flexible Schedules Reduced Summer Hours Work From Home Policy CPE Exam Reimbursement Health and Wellness Benefits Mentorship and Learning Development

We are seeking highly motivated individuals to join our firm's audit division. Our Certified Public Accounting firm specializes in independent financial statement audits and single audits. We offer great opportunities for professional fulfillment and advancement in public accounting, balanced with individual needs. We provide flexible schedules, unlimited paid time off accrual, remote work, and an opportunity to work with an awesome team of professionals. Our firm is lead with compassion and greatly values mental health of team. We recently opened a state-of-the-art office in Secaucus, NJ that exemplifies our commitment to our team and every individual on it. Responsibilities and Duties Audit associates will go through comprehensive training and will then be initially assigned audit testing and analysis under the supervision of experienced team members to gain a better understanding of accounting and internal controls. Audit associates are developed as both accountants and critical thinkers. Some light and local travel will be required to clients in northern New Jersey. Qualifications and Skills Individuals should have a bachelor's or master's degree in accounting. Some experience is preferred, but not required. Culture and Compensation At DGDT, what you do matters! We see business and government from many perspectives. Our unique expertise and experience along with our belief that when what you do matters, what we do matters, is what makes us one of New Jersey's most highly regarded firms. We pride ourselves on caring by providing dynamic, expert, highly individualized services to clients ranging from private individuals and businesses to local governments and nonprofits. We have a great team environment and are always invested in growing our members. Competitive salary and benefits including: Health insurance Dental insurance Life insurance 401(k) Unlimited paid time off accrual Flexible schedule

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. * Performs sampling of components. * Conduct verifications and checks through accurate material inspections. * Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system * Management of BPCS for verification and disposition of materials * Maintain retain samples for all primary and secondary components and labeling * Performance of DAF (Destruction Approval) process for rejected materials * Use of Trackwise and Veeva for change controls, as needed * Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements * Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. * Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. * Support generation of logbooks and sheets/labels as required. * Basic knowledge of cGMPs and supporting regulatory documents * Perform room, area and equipment clearances that may be necessary for this job function. * Able to perform tasks with minimal error rate. * Assist other Quality Assurance Operations Associates, as needed. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. * At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. * Must be able to do work independently. * Experience in QA working in a cGMP manufacturing environment (preferred) * Working knowledge and understanding of quality assurance principles and familiarity with QA programs * Strong analytical skills, attention to detail and adherence to procedures. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. 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