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  • Quality Assurance Manager

    Clinlab Solutions Group

    Quality assurance specialist job in Hamilton, OH

    DAP Quality Assurance Manager - West Chester, Ohio My client is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. Position Summary The Manager, Quality Assurance will be accountable for all QA activities and decisions to directly support GMP production operations in a Process Execution Team (PET). These activities and decisions include change control, technology transfer and project support, documentation, equipment and process validation, deviation investigations, SOPs, and regulatory interactions and may also include medical device management support. This role will evolve to provide leadership, daily support, and supervision of GMP operations. The Manager, Quality Assurance will develop a quality support program for technical projects programs to support GMP manufacturing, and the training of QA personnel, and also be responsible for overseeing the daily activities of QA staff. Position Responsibilities Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET) Accountable for all QA decision-making in the PETs; works with the PET leaders and other team members to deliver all PET and site objectives. Provide direction, development, and performance management to the Quality professionals supporting the PET. Accountable for the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and the equipment and facilities utilized by the PET: Change Management (Change controls) Quality Investigations (Deviations, supplier deviations) Support Technical Transfers, Validation Plans, Protocols, and other technical reports. Standard Operating Procedures & Risk Assessments Medical device management and support Accountable for the release of incoming materials (bulk, APIs, excipients, packaging components, and so on.) Team management Support the site to ensure a safe working environment, including leading your team's safety efforts. Supervise, coach, and assist with employee development and performance management; ensure a fair and equitable workplace. Collaborates with other managers and Quality professionals from other PETs (including other sites) to ensure consistent application of the key quality systems across all PETs. Interfaces with the Site Support Groups on improvement projects (capital and noncapital) that impact the PET, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management. Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring, and consultation to the PET leader and PET members. Ensures that the QA processes including batch documentation review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives. Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the workgroup. Minimum Qualifications Experience in a position of people leadership Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies Ability to influence leaders in a matrix environment, as well as the personal conviction to make courageous decisions to ensure patient safety and safeguard the company's reputation. Preferred Qualifications Five years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry Advanced degree, bachelor's degree or higher Multiple site or functional experience Experience with medical device regulations Demonstrated problem-solving and decision-making skills Ability to direct and participate in cross-functional teams. Advanced knowledge of regulatory agency interactions and compliance procedures, with the ability to apply the knowledge in an operation environment
    $74k-110k yearly est. 4d ago
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  • Quality Assurance Compliance Specialist

    Kelly Science, Engineering, Technology & Telecom

    Quality assurance specialist job in Cincinnati, OH

    Kelly Science & Clinical is seeking a Senior Quality Assurance Coordinator near Cincinnati, OH. Role Purpose The Senior Quality Assurance Coordinator plays a strategic and transformative role in modernizing and strengthening the Quality Management System (QMS) and compliance framework across food, cosmetic, pharmaceutical, and specialty chemical operations. This position oversees quality activities spanning four production units, including two major manufacturing sites in the Cincinnati region. Operating with a high degree of autonomy, the Senior QA Coordinator is instrumental in shaping quality systems to drive operational excellence, customer confidence, and scalable growth. More than day-to-day compliance, this role leads enterprise-level QMS development, governance, and continuous improvement, and is pivotal in evaluating, selecting, and implementing next-generation Quality software to replace existing platforms. This position serves as the primary liaison between Quality, Operations, IT, Regulatory, and external partners to ensure scalable, future-ready quality systems. Key Responsibilities QMS Leadership & System Transformation Serve as enterprise quality lead for design, implementation, governance, and continuous improvement of the global QMS. Own the QMS transformation roadmap, including documentation architecture, workflow design, system integration, performance metrics, and governance standards. Act as business owner for the future-state QMS ecosystem, encompassing digital quality platforms and data governance. IQS Replacement & Digital Quality Enablement Lead strategy and project implementation for the next-generation QMS platform. Collaborate with IT, Operations, Regulatory, and external vendors to define requirements, manage migration, drive user adoption, and ensure sustainable change management. Ensure that new systems strengthen audit readiness, traceability, CAPA, complaints management, document control, and regulatory reporting. Audit Leadership & Compliance Execution Lead the execution and reporting of external audits (customer, regulatory, certification, supplier). Plan and conduct supplier and service audits, producing formal reports and managing corrective action follow-up. Serve as a senior technical authority on GMP, ISO, GFSI, FDA, and customer compliance requirements. Enterprise Quality Partnership Serve as a strategic quality partner to Operations, Supply Chain, Commercial, R&D, and Corporate functions across multiple production units. Provide executive-level insight on compliance risks, emerging trends, and quality performance. Design and deliver quality training programs and present complex quality topics to large groups. Project Leadership & Continuous Improvement Lead complex, cross-functional quality projects using established project management methodologies. Drive Kaizen, root cause investigations, and continuous improvement initiatives throughout the manufacturing network. Establish and maintain enterprise KPIs and dashboards for monitoring QMS performance and compliance health. Key Requirements Education Bachelor's degree in Quality, Science, Engineering, or related field required. Advanced degree or relevant certifications strongly preferred. Experience Minimum 3-5 years of progressive experience in a GMP manufacturing and/or laboratory environment. Demonstrated success in leading QMS programs, audits, and system transformation projects. Certifications Certified Quality Auditor (e.g., ASQ, ISO, GFSI, GMP or equivalent) required. Internal Auditor certification (ISO 19011) preferred. Proven ability to perform and document a range of audits (internal, external, supplier, and regulatory). Technical & Systems Expertise Advanced experience with QMS/LMS platforms. Expertise in leading digital quality system implementations and enterprise platform design. Strong knowledge of ERP systems, SharePoint, and document control infrastructures. Leadership & Execution Capability Proven experience managing cross-functional projects. Strong technical writing and communication skills. Ability to work independently with high accountability and authority. Experienced in presenting to large groups and facilitating senior-level quality discussions. Travel Willingness and ability to travel up to 20% to support multi-site operations and audits.
    $42k-70k yearly est. 1d ago
  • Quality Supervisor

    Central Transport 4.7company rating

    Quality assurance specialist job in Vandalia, OH

    : Central Transport LLC is one of the nation's most reliable and technologically advanced LTL (Less-than-Truckload) carriers to date. We are privately owned and have been servicing manufacturing & retail companies of all sizes for over 90 years now. With over 200 locations around the country, we pride ourselves on the continuous expansions that we have made and are still making strides to improve our operation systems to better service our wide network of clientele. Earlier this year, our business levels have reached the highest they've ever been; breaking our personal record that had been set the previous year. We like to credit our growing success with our ability to develop and provide opportunity for our team of employees so they can make advancements within our company. Our company values a positive attitude and the mindset of a winner. This position offers a competitive salary and benefits package, 401(k), paid vacation and life insurance. Role Description: We are currently seeking a Quality Supervisor (HU Control Supervisor) for our facility located out of Vandalia, Ohio. We are looking for experienced, detailed-oriented, forward thinking, and highly motivated candidates to serve as a leader amongst the department. If you love a challenge and are looking to take a step towards a rewarding career, this Quality Supervisor opportunity may be right for you. These individuals will report directly to HU Control at the Corporate headquarters and will not be absorbed into normal freight movement. They will work closely with other HU Control Hub Quality individuals as well as HU Control at the Corporate Office to produce a quality product for the movement of all freight in and out of the location. Shift: 2:00p.m. - 12:00a.m. Monday - Friday. Salary Range: $60,000 - $75,000 + up to 10% in bonuses The ideal candidate will possess the following: A bachelor's degree is preferred but not required 3-plus years of experience in LTL, distribution/logistics, transportation, operations management or knowledge of LTL freight movement Excellent written and verbal communication skills Knowledge of HU Control functions Knowledge of computer systems and handheld scanning technology Willingness to work off shifts Duties include, but are not limited to: Proper investigation on reported overages, shortages and damages involving the terminal Prevention and recuperation of customer goods due to damages Overseeing and enforcing outbound load quality Providing disciplinary action for load quality from other terminals Taking inventory of load bars and other tools that are used to secure the freight Daily, weekly and monthly reporting on all OS&D findings
    $60k-75k yearly 4d ago
  • Regulatory Document Compliance Specialist

    Gold Medal Products Company 4.3company rating

    Quality assurance specialist job in Cincinnati, OH

    For over 90 years, Gold Medal has been a leader in the concession industry for both equipment and supplies including popcorn, cotton candy, Sno-Kones and much more. Gold Medal is a family-owned business with an excellent culture. We are proud to have been awarded the Best Place to Work in Cincy Magazine's 2020 Manny Awards. Due to our continued growth, we are excited to announce a Regulatory Document Compliance Specialist opportunity available at our Cincinnati location. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Food Labeling: 1. Develops and maintain accurate food labeling information for finished products compliant with FDA and USDA regulations. 2. Ensures that all on label claims are substantiated and that certifications and allergens are properly documented. 3. Provides technical guidance and addresses compliance related questions involving existing, new and reformulated products. · Business Engagement: 1. Actively participates in cross functional meetings that support product change/innovation. 2. Supports process improvement and label policy changes 3. Effectively communicates technical reasoning through research and make appropriate recommendations. 4. Collaborates with Legal, Product Development, Quality Assurance, Government Agencies, Supply Chain Vendors, and external trade associations. · International Support: 1. Generates documentation required to support international export markets engaging with USDA, APHIS, AMS and FDA. · Other Compliance: 1. Conducts technical reviews, both ingredient and recipe, for products sold domestically and internationally. 2. Has a working knowledge of International Food Additive and Food Labeling regulations to support regulatory review and compliance processes as needed. 3. Knowledge to maintain certification programs (Kosher, Halal). 4. Obtains and maintains current specifications for Raw Material, Packaging, Finished Goods and Re-sale products for the Approved Supplier Program. 5. Maintains FDA and USDA Facility Registrations for both corporate and branch locations. 6. Creates and maintains Product Data Sheets for Manufactured and Re-sale items. · Perform special projects as required by management. QUALIFICATIONS: · Education: Bachelors degree in a Science Related Field (Food Nutrition, Food Science, Biology, Chemistry) or equivalent preferred · Experience: Previous Food Documentation Compliance preferred COMPENSATION/BENEFITS: Competitive compensation package including profit sharing. Excellent benefits including: o Medical - We pay 90% of weekly premiums for employees o Dental o Vision o Disability insurance o Life insurance o Paid Time Off o 401(k) with Company match o Company paid holidays Gold Medal is an equal opportunity employer.
    $45k-69k yearly est. 1d ago
  • Manufacturing Quality Assurance & Control Specialist

    Hillenbrand 4.8company rating

    Quality assurance specialist job in Sidney, OH

    Shift 1 (United States of America) As a Manufacturing Quality Assurance & Control Specialist you will be a vital part of our manufacturing and Coperion Food Equipment (Shaffer Peerless) team, ensuring that our equipment meets the highest standards of quality and reliability. This position offers the opportunity to apply your technical expertise and attention to detail to support our commitment to delivering exceptional products. Based onsite in Sidney, OH you will play a key role in safeguarding product integrity through meticulous inspection and quality processes. What You'll Do Conduct final inspections of manufactured equipment prior to shipment, verifying mechanical operation and electrical/control systems to ensure compliance with quality standards. Utilize detailed blueprints, official quote documents, Certified Data Sheets, drawings, and Bills of Material to perform precise inspections of internal and external components. Use a variety of measurement tools such as calipers, micrometers, and gauges to verify dimensions and tolerances, ensuring parts meet specified requirements. Document inspection results, discrepancies, and measurements accurately, preparing clear reports for internal teams and management. Lead the identification and communication of deviations or defects, facilitating prompt resolution through collaboration with cross-functional teams. Operate hand tools and power tools for inspection, adjustments, or minor repairs as needed. Assess warranty parameters to determine if parts qualify for return, replacement, or further action. Support continuous improvement initiatives and assist with internal audits and process enhancements. Perform additional tasks as assigned by supervisors to uphold quality standards and operational excellence. Team: You will be an integral member of our manufacturing site, working closely with manufacturing, engineering, and production departments. You'll collaborate with various functional areas to uphold our commitment to quality and customer satisfaction. Basic Qualifications Minimum 3 years of formal experience in a QA role in a manufacturing/production environment. Proven experience reading blueprints, engineering drawings, Bills of Material, and Certified Data Sheets. Experienced in using precision measurement tools such as calipers, micrometers, and gauges. Ability to operate hand tools and power tools safely and effectively. Strong attention to detail with a focus on accuracy and quality. Effective communication skills for documenting findings and collaborating with team members. Ability to work independently and as part of a team in a fast-paced environment. Advanced understanding of warranty procedures and quality standards, including familiarity with ISO, ANSI, or similar standards. Preferred Qualifications 5+ years formal experience in a manufacturing environment as a Quality Assurance Analyst/Technician or similar. Knowledge of electrical and mechanical systems inspection. Experience leading or participating in continuous improvement initiatives. Strong problem-solving skills and the ability to interface with customers or suppliers in resolving quality issues. Familiarity with industry standards and best practices for quality management. #LI-EP2 #LI-ONSITE Who we are: Coperion is an industry leader in compounding and extrusion, feeding and weighing, bulk material handling and service, bringing a wealth of know-how and experience to the market. Customers benefit from Coperion's divisions of Polymer, Equipment & Systems, and Service that are optimally networked on a global basis to offer ultimate support in the design, manufacturing and implementation of ideal systems. Staffed by engineers, chemists, technicians and a variety of industry experts, these Divisions form a powerhouse of process solutions for their customers. Coperion is an Operating Company of Hillenbrand. Hillenbrand (NYSE: HI) is a global industrial company that provides highly-engineered, mission-critical processing equipment and solutions to customers in over 100 countries around the world. Our portfolio is composed of leading industrial brands that serve large, attractive end markets, including durable plastics, food, and recycling. Guided by our Purpose - Shape What Matters For Tomorrow™ - we pursue excellence, collaboration, and innovation to consistently shape solutions that best serve our associates, customers, communities, and other stakeholders. To learn more, visit: ******************** EEO: The policy of Hillenbrand Inc. is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status. Additionally, Hillenbrand Inc. and our operating companies are committed to being an Equal Employment Opportunity (EEO) Employer and offers opportunities to all job seekers including individuals with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, email us at recruitingaccommodations@hillenbrand.com . In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying. At Hillenbrand, everyone is welcome to apply and "Shape What Matters for Tomorrow".
    $64k-90k yearly est. Auto-Apply 2d ago
  • Quality Assurance Specialist - Electrical

    Accelevation

    Quality assurance specialist job in Miamisburg, OH

    We build what the future runs on. Accelevation designs, manufactures and installs the physical infrastructure that powers today's most advanced technologies. We've grown over 440% in the last 18 months because we take ownership, solve hard problems, and build with purpose. Join us to build the future. Your Impact As the Quality Assurance Specialist - Electrical, you'll ensure that all electrical work meets the highest standards of safety, compliance, and craftsmanship. Your expertise will drive accuracy, reliability, and continuous improvement across our electrical systems-ultimately supporting operational excellence and customer satisfaction as we scale. Your Day-to-Day Responsibilities Lead electrical quality assurance activities for installations, assemblies, and components. Develop and maintain electrical inspection checklists, testing procedures, and acceptance criteria. Review drawings, work orders, and specifications to confirm design intent and compliance with standards. Conduct root cause analysis and support corrective and preventive actions (CAPA) for electrical nonconformities. Partner closely with Engineering, Production, and Field Teams to resolve issues and implement best practices. Provide training and mentorship on electrical workmanship, testing methods, and safety requirements. Participate in internal and external audits-including customer, ISO 9001, and regulatory audits. Maintain accurate inspection records, test data, and quality documentation for full traceability. Support standardization and continuous improvement across all electrical processes. Perform additional duties as assigned. Qualifications Active Journeyman or Master Electrician License (must be current and verifiable). Minimum 3 years of hands-on electrical experience in commercial, industrial, or manufacturing environments. Understanding of electrical testing, troubleshooting, and verification methods. Proficiency in reading and interpreting blueprints, wiring diagrams, and schematics. Exceptional attention to detail and documentation accuracy. Strong communication and interpersonal skills. Proficient in Microsoft Office. Preferred Qualifications Strong knowledge of NEC, NFPA 70E, and UL standards. Experience in a manufacturing or assembly environment subject to ISO 9001. Prior experience with QA/QC systems, auditing, or process improvement. Familiarity with control panels, switchgear, or industrial automation systems. Benefits Competitive salary and performance bonus (if applicable) Paid time off 401(k) retirement plan with company match Comprehensive health, dental, and vision insurance First time homebuyer program (if applicable, based off comp) Collaborative, high-energy workplace Our Core Values Safety - We proactively protect our people and environment Inclusion - We respect and appreciate diverse perspectives and backgrounds Speed - We move fast, act decisively, and stay agile Innovation - We challenge assumptions and simplify processes Judgment - We make sound decisions with the business in mind Accountability - We take ownership and deliver results Job Application Notice Accelevation LLC does not ask for payment or sensitive personal details, such as bank account or Social Security numbers, during the job application process. If you're unsure about a job posting, apply directly at **************************** to stay safe. Equal Opportunity Employer Accelevation LLC is an equal opportunity employer. Inclusion is one of our core values - we build teams that celebrate and embrace diversity, fostering a culture of respect for all. As part of our pre-hire process, we may conduct a background check and use E-Verify to confirm employment eligibility.
    $43k-72k yearly est. 33d ago
  • Quality Assurance Specialist

    Global Channel Management

    Quality assurance specialist job in Mason, OH

    Quality Assurance Specialist needs claims , appeals , call center experience Quality Assurance Specialist requires: Hybrid of 2 days/week Works grievance and appeals Prior work experience (G&A, claims, appeals, call center, etc.) Strong written and verbal communication skills, and health claims processing background Quality Assurance Specialist duties: Review and resolve member and provider complaints Maintain accurate, complete complaint/grievance records in the electronic database. Coordinates Complaint , preparing the agenda Notifying participants,
    $43k-71k yearly est. 60d+ ago
  • QA/QC Manager (Project Based)

    Baker Construction 4.5company rating

    Quality assurance specialist job in Cincinnati, OH

    Company Name: Baker Concrete Construction, Inc **Req ID** : 6922 **Travel:** Up to 100% **Number of Openings:** 1 Achieve more in your career with the nation's leading specialty concrete contractor. At Baker Construction, you'll be part of a team that prioritizes people, invests in their development, and offers unparalleled opportunities for professional growth. In this role, you'll be integral to building the future of our country and our company. You'll collaborate across diverse teams, have a hand in significant projects, and dive headfirst into complex challenges with the best in the industry. If you are driven to do more and have the grit to follow through, you'll have everything you need to define your career on your terms. Make a meaningful impact with a team that values ambition and rewards initiative. Apply today and be more with Baker. **Summary** The **QA/QC Manager** assists in the direction of all site quality assurance and quality control activities. Serves as a technical specialist in one of more areas. Assists in defining inspection processes and certifying co-workers who perform inspections and manages the inspection staff. Typically Certified as Inspector Level II or III in various disciplines. **Roles and Responsibilities** The QA/QC Manager will perform the following duties in a safe, productive, and effective manner: + Assign staff according to QA/QC needs including inspections and audits. May supervise QC Level I, II, or III inspectors + Oversees applicable quality assurance documentation generated, assembled, and maintained for a specific project + Ensures all records are reviewed for legibility, completeness, traceability to the item, and conformance to specified acceptance standards + Assists in defining inspection processes and certifying co-workers who perform inspections + Assists in development and implementation of Company/Project QA/QC program in accordance with owner and/or regulatory requirements including the preparation of manuals, standards, procedures, developing training programs + Directs qualified inspection and test personnel to perform their applicable quality-related activities + Reviews and approves test controls and test results. Perform vendor inspections and witness tests as required + Conducts inspections, audits, etc. to ensure company-wide compliance with quality and safety programs. Identify any violations and institute corrective measures as required + Conducts internal and/or supplier/subcontractor audits and surveillances. Verifies that the items received conform to the acceptance criteria required by the contract + Assigns staff according to QA/QC needs including inspections and audits. May supervise QC Level I, II, or III inspectors + Oversees applicable quality assurance documentation generated, assembled, and maintained for a specific project + Ensures all records are reviewed for legibility, completeness, traceability to the item, and conformance to specified acceptance standards + Assists in defining inspection processes and certifying co-workers who perform inspections + Assists in development and implementation of Company/Project QA/QC program in accordance with owner and/or regulatory requirements including the preparation of manuals, standards, procedures, developing training programs + Directs qualified inspection and test personnel to perform their applicable quality-related activities + Reviews and approves test controls and test results. Perform vendor inspections and witness tests as required + Conducts inspections, audits, etc. to ensure company-wide compliance with quality and safety programs. Identify any violations and institute corrective measures as required + Conducts internal and/or supplier/subcontractor audits and surveillances. Verifies that the items received conform to the acceptance criteria required by the contract + Documents and facilitates corrections of non-conformances + Provides guidance, direction, coaching, and support to direct reports to maximize individual and overall department performance. Ensures support managers within area of responsibility also provide guidance, direction, etc. to their direct reports + Responsible for holding timely performance appraisals and progress reviews + Assists direct reports and staff in developing short and long-term goals that align with department and Company mission and strategy + Ensures direct reports and staff receive appropriate training that aligns with career development plans. Training may be remedial, "maintenance", or geared to promotion + Conducts department staff meetings and participates in developing initiatives, goals, objectives, systems, policies, and procedures + Collaborates with HR to ensure compliance with all employment laws, labor laws, and related Company policies; may be responsible for conducting training or coordinating workshops related to such compliance **Requirements** + Bachelor's degree in an engineering, scientific, or construction-related discipline from an accredited college or university and 6 years' related experience and/or training; or equivalent combination of education and experience + Knowledge of construction practices (i.e., formwork, rebar, concrete placing, etc.) + Quality assurance-related experience preferably in the nuclear power industry (DOE/DOD facilities) + Quality inspector experience + Demonstrated skill and knowledge with applicable quality codes and standards and preferably NRC regulations + Proficiency in Microsoft software programs such as Word, Excel, and PowerPoint + Proficiency in SharePoint/FileNet and Blue Beam software programs The following competencies are needed to successfully perform this job: + Ability to read, analyze, and interpret general business documents, technical procedures and government regulations, codes and standards + Ability to write coherent reports, business correspondence, and procedures + Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public + Ability to understand, customize and modify spreadsheets. + Good listening skills + Ability to apply concepts such as fractions, percentages, ratios, proportions, geometry, trigonometry and interpolation to practical situations + Ability to direct work and evaluate strengths and weaknesses of co-workers + Ability to work in a team environment + Ability to be assertive and persuasive + Ability to define problems, gather data, establish facts, and draw valid conclusions At Baker Construction, we welcome those who are driven to make things happen. Your tenacity will be rewarded with great pay, excellent benefits, and opportunities to make your mark. This is an opportunity to own your future while working alongside co-workers who are united in our purpose to build better structures and better lives. Go further with an industry leader that puts people first, honors its word, and has the grit to achieve greatness. Baker is an EOE Disability/Veterans Employer. Applicants with physical and/or mental disabilities who require a reasonable accommodation for any or part of the application process may make their requests known by emailing ************************ or calling ************** and asking for HR.
    $88k-120k yearly est. 57d ago
  • QA Specialist (on-site)

    Pharmalogic Holdings

    Quality assurance specialist job in Cincinnati, OH

    Job Description PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside. PharmaLogic offers you an exceptional opportunity to join our dynamic team as an On-Site QA Specialist! Hours - 10:00 PM to 6:00 AM As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance. The position involves a hands-on role in all quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, drug quality control, sterility, environmental monitoring, equipment maintenance / qualification/ calibration, investigation (IR, OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions. The QA Specialist is responsible for assisting in FDA inspections at the site. Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA Specialist may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management. Job Responsibilities and Duties: Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety. Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary. Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity. May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment May perform aseptic processing related tasks Responsible for quality assurance oversight of routine production, packaging and shipping of radioisotopes. Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met. Assure approved vendors used and maintain documents and records, including COA. Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members. Perform batch trending analysis. Notify facility manager if any recall necessary to assure that recalled materials are not administered to patients. Initiate change to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS. Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management. Document and Trend deviations, IRs, events and initiate investigation and assure documentation of corrective actions and retraining as applicable. Initiate and complete CAPA investigation as deemed necessary, and report results and trends. Maintain facility compliance with environmental monitoring and aseptic control, Review and trend environmental monitoring results and all testing records. Maintain records for inspection. Perform annual retraining upkeep of training files. Assure aseptic processing of samples and products, as per SOP. Assure aseptic processing area suitably cleaned, maintained, controlled to prevent mix-ups or contamination; assure personnel qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes used according to SOP. Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications. Assure equipment is functional, within calibration, suitable for use, maintained and documented per SOP. Assure equipment qualified and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents. Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies reported to PharmaLogic Quality and Regulatory. Assist in maintaining records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management. Support the site lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records, personnel, and facility review. Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review. Draft ANDA related documents for submission including annual reports and other updates as required. Assists in conducting periodic and annual quality audits, training, SOP review and other activities as directed Job Requirements │ Skills │Education: BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 1-3 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience preferred. Pharmacy tech certification a plus; experience with aseptic technique a plus Experience working with ionizing radiation and laboratory equipment desirable including troubleshooting and repairs. Strong analytical, critical thinking and customer service skills. Experience working on a cross-functional team in fast-paced environment. Strong knowledge of cGMP environment and regulations. Knowledge of CFR21 Part 212 preferred. Strong attention to detail and experience with managing multiple projects and priorities. Come join our winning team and begin a fulfilling career with us by applying today. PharmaLogic 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 veteran status, or any other protected class. Benefits Include: 401(k) retirement benefit program Medical Dental care Disability insurance Employee assistance program Life insurance On-site parking Paid time off Vision care Hours - 10:00 PM to 6:00 AM 40 hours/week
    $42k-70k yearly est. 11d ago
  • Quality Assurance Specialist

    AAA Mid-Atlantic

    Quality assurance specialist job in Cincinnati, OH

    AAA Club Alliance is seeking a Quality Assurance Specialist to join our team. This position can be based at our offices located in Wilmington, DE, Lexington, KY, or Cincinnati, OH. This is a hybrid role and will require you to be on-site Tuesday, Wednesday, and Thursday. The primary duties of the Quality Assurance Specialist are: * Collects and inputs survey results. Able to scrub and organize data for analysis. Monitors call content for technical knowledge and customer service. * Responsible for reviewing survey data (Qualtrics), researching call data (Sales Force) and may require monitoring or evaluation(Genesys Cloud) of Contact Center agents and other operations associates to ensure that the professional and quality of information disseminated is correct. * Provides input for improvement of methods and policies. Prepares reports summarizing performance relative to the monitoring program. Participates in regular calibrations with respective management staff. * Responsible for providing weekly/monthly assurance reports to Analyst and Manager. Assists in the organization, review, evaluation and summarization of data to identify trends and opportunities for all business lines Minimum Qualifications: * Associate's degree or equivalent. * 2 years customer service and/or quality assurance experience. * Possess a strong background in customer service, quality monitoring, report trending and analysis. * MS office - working knowledge with Access and Excel. * Willingness to become familiar with Automotive systems: Sales Force, Genesys and Reporting Qualtrics, BIA. At AAA, your success is our success. What we can offer you: * The starting pay range for this position is $21.13 to $32.88. * The base pay range shown is a guideline for compensation and ultimate salary offered will be based on factors such as applicant experience and geographic location.* * Comprehensive health benefits package. * Up to three weeks of paid time off accrued during your first year. * 401(K) plan with company match up to 7%. * Professional development opportunities and tuition reimbursement. * Paid time off to volunteer & company-sponsored volunteer events throughout the year. * Other benefits include a free AAA Premier Membership, Health & Wellness Program, Health Concierge Service, Health & Life Insurance, Short Term/Long Term Disability. Full time Associates are offered a comprehensive benefits package that includes: * Medical, Dental, and Vision plan options * Up to 2 weeks Paid parental leave * 401k plan with company match up to 7% * 2+ weeks of PTO within your first year * Paid company holidays * Company provided volunteer opportunities + 1 volunteer day per year * Free AAA Membership * Continual learning reimbursement up to $5,250 per year * And MORE! Check out our Benefits Page for more information ACA is an equal opportunity employer and complies with all applicable federal, state, and local employment practices laws. At ACA, we are committed to cultivating a welcoming and inclusive workplace of team members with diverse backgrounds and experiences to enable us to meet our goals and support our values while serving our Members and customers. We strive to attract and retain candidates with a passion for their work and we encourage all qualified individuals to apply. It is ACA's policy to employ the best qualified individuals available for all positions. Hiring decisions are based upon ACA's operating needs, and applicant qualifications including, but not limited to, experience, skills, ability, availability, cooperation, and job performance. Job Category: QA - Quality Control
    $21.1-32.9 hourly Auto-Apply 9d ago
  • Quality Assurance Documentation Specialist

    Actalent

    Quality assurance specialist job in Vandalia, OH

    Quality Assurance Technician INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT ************** TO SET UP A PHONE INTERVIEW! This role is fully documentation with little to no lab work. Job Description The Quality Assurance Technician will perform quality control inspection and disposition of materials and products according to established specifications. This role ensures compliance with applicable FDA, state OSHA, and ISO regulations and standards by performing QC inspections using measuring instruments and inspection methods. The technician will identify and manage non-conforming materials or products in accordance with the Quality System and perform a variety of tasks under limited supervision. Responsibilities + Perform reviews of batch production records and manufacturing records as part of lot release activities. + Coordinate and track CAPA, NCR, and Deviation records, ensuring timely completion of tasks. + Coordinate and track the site environmental monitoring (EM) testing program. + Assist teams in problem solving and root cause analysis for quality events. + Develop, review, and release quarterly EM trending reports and bring significant trends to management attention. + Provide input based on knowledge and experience with batch release requirements. + Support QMS Operations related activities for all CGMP departments. + Conduct Quality Control activities at processing or distribution sites, including inspections of incoming materials, in-process, and finished products. + Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices. + Support gowning qualification and training. + Ensure timely issuance, review, and approval of Microbiology and EM testing results. + Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies. + Assist in the review and approval of equipment qualifications. + Assist in the review of Calibration and Preventative Maintenance reviews. + Assist in hosting onsite regulatory audits and inspections. Essential Skills + Bachelor's Degree in a Life Science discipline or related field. + 1-2 years of relevant industry experience with GMP, GDP, or GXP, within a Medical Device, Pharmaceutical, or Tissue commercial organization. + Experience in an FDA-regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing. + Proficiency in Microsoft Excel. + Experience writing Standard Operating Procedures and Work Instructions. + Familiarity with Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations. Additional Skills & Qualifications + Knowledge in biology, human tissue, skin processing, and compliance. Work Environment The position is primarily desk-based with some inspection duties and occasional work in clean rooms or labs. Candidates should be comfortable working around human tissue. Work hours are flexible and may include shifts: 1st shift Monday-Friday 7:00 AM-3:30 PM, and 2nd shift Monday-Friday 3:00 PM-11:30 PM. The work setting includes a brand-new, state-of-the-art facility in Vandalia, OH, reflecting a company experiencing rapid growth. Job Type & Location This is a Contract position based out of Vandalia, OH. Pay and Benefits The pay range for this position is $26.50 - $26.50/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 Vandalia,OH. Application Deadline This position is anticipated to close on Jan 24, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $26.5-26.5 hourly 4d ago
  • Technical Documentation Specialist

    Lancesoft 4.5company rating

    Quality assurance specialist job in Mason, OH

    Contract Remote Role | Technical Documentation Specialist 3 months contract with possible extension Pay Range: $35 - 45/hour on w2 Job Description: Specialized resource will be responsible for creating proof of claims documents for North America Hair care innovation, focused on Head and Shoulders and possibly Pantene. Generation of defendable proof of claims documents for product claims and marketing copy. Must Have: Individual must have a strong working knowledge of *** Hair Care technology, Hair structure & function, Hair technical methods & endpoints, the claim support process, the POC system of record in Hair Care, self directed and accountable with clear/logical writing skills.
    $35-45 hourly 9d ago
  • Quality Assurance Associate

    Hikma 3.7company rating

    Quality assurance specialist job in Dayton, OH

    Job Title: Quality Assurance Associate Job Title: Quality Assurance Associate Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated [Job Title] to join our team. In this role, you will be responsible for [briefly describe key responsibilities and tasks]. You will work closely with [mention teams or departments the role collaborates with] to [describe the role's contribution to the company's success. Job Purpose: Under the supervision of the Quality Assurance Supervisor, this person is responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels. Ensure compliance of operations personnel with the company's procedures and Good Manufacturing Practices (GMPs). This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required. Key Responsibilities: • Regular and predictable onsite attendance and punctuality. • Perform monitoring of Compounding in the aseptic processing area. • Perform AQL inspection for Finished products • Perform in-coming raw material, component, and labeling inspection and release • Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors. • Provide Quality support to Manufacturing personnel on the floor - providing guidance during GMP events and initiation of deviations and investigations. • Lead small scope projects, as assigned. • Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance. • Prepare all necessary reports in a timely manner to meet compliance requirements and business needs. • Participate in Process Validation activities, including protocol execution and reporting, as necessary. • Working knowledge of FDA regulations and application of GMPs. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: • Minimum: Associates Degree in Science or equivalent with 2 to 5 years applicable Quality Assurance experience. • Preferred: Bachelor's Degree in Science or equivalent with 1-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred) Compensation: Base Salary: $ 65,000 to $ 75,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: • Annual performance bonus, commission, and share potential • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries • 3 personal days (prorated based on hire date) • 11 company paid holidays • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits • Employee discount program • Wellbeing rewards program • Safety and Quality is a top organizational priority • Career advancement and growth opportunities • Tuition reimbursement • Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $65k-75k yearly 60d+ ago
  • Associate II, Quality Assurance (Night Shift)

    National Resilience, Inc.

    Quality assurance specialist job in Olde West Chester, OH

    A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit ****************** Position Summary: This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role. Position Responsibilities: Maintain a high level of understanding of relevant production processes and quality systems Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests Batch Records and associated documentation Product and Component Release transactions in SAP Quality Investigations (Deviations, Product Complaints) Validation Plans, Protocols and Reports Standard Operating Procedures Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders Collaborate in data analysis and report creation on quality metrics and key performance indicators Hours (Night Shift): 6pm - 6:30am 2/2/3 Schedule (12-Hour Rotating) Minimum Qualifications: Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance Excellent oral and written communication skills Strong ability and motivation to learn Preferred Qualifications: Bachelor's degree; master's degree in quality assurance/regulatory affairs is desirable Previous experience in a Lean, process-centric organization with emphasis on continuous improvement Multi-site / multi-functional experience The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $60,000.00 - $90,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
    $60k-90k yearly Auto-Apply 16d ago
  • Associate II, Quality Assurance

    Resilience 4.4company rating

    Quality assurance specialist job in Olde West Chester, OH

    A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit ****************** Position Summary: This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role. Position Responsibilities: Maintain a high level of understanding of relevant production processes and quality systems Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests Batch Records and associated documentation Product and Component Release transactions in SAP Quality Investigations (Deviations, Product Complaints) Validation Plans, Protocols and Reports Standard Operating Procedures Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders Collaborate in data analysis and report creation on quality metrics and key performance indicators Hours (Day Shift): 6am - 6:30pm 2/2/3 Schedule (12-Hour Rotating) Minimum Qualifications: Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance Excellent oral and written communication skills Strong ability and motivation to learn Preferred Qualifications: Bachelor's degree; master's degree in quality assurance/regulatory affairs is desirable Previous experience in a Lean, process-centric organization with emphasis on continuous improvement Multi-site / multi-functional experience The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $60,000.00 - $90,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
    $60k-90k yearly Auto-Apply 8d ago
  • Quality Control Specialist

    General Electric Credit Union 4.8company rating

    Quality assurance specialist job in Cincinnati, OH

    General Electric Credit Union is a not-for-profit, member-owned full service financial institution headquartered in Cincinnati with branches in Ohio and Kentucky. At GECU, we pride ourselves on maintaining quality service, being an employee-friendly workplace, and developing our team members while teaching you the skills to lead you to career advancement opportunities. Overview: The Quality Control Specialist is responsible for supporting compliance of credit union operations by ensuring accuracy and completeness of various documents related to deposit accounts, loans, mortgages, or other specialized accounts and reviewing reports to verify adherence to federal and state regulations, thereby playing a critical role in identifying and mitigating risk. Essential Responsibilities: Review business deposit and commercial loan accounts within the required timeframe, ensuring accuracy and compliance with federal/state regulations and GECU guidelines Review specialized accounts, including estate and trust accounts, to ensure compliance with federal/state regulations Review tracking spreadsheets and procedures related to deposit accounts, loans, mortgage, and account maintenance with internal staff, recommending strategies to prevent errors Train team members Perform other duties to support the department as necessary Education and Experience: High school diploma or GED required; bachelor's degree in business, finance or related field preferred Minimum of three years of auditing or financial quality control experience within the financial industry Knowledge, Skills, and Abilities: Strong understanding of federal and state regulations related to financial institutions including various types of deposit accounts and loans High level detail-orientation with a focus on accuracy Good analytical and problem-solving skills Excellent written and verbal communication skills Effective time management with the ability to prioritize tasks Proficiency in Microsoft Office Suite At GECU, we want to support your wellbeing by offering a wide range of benefits: Health, Dental and Vision insurance Life and Disability insurance options Paid Time Off starts accruing once hired and take your birthday off - paid 401k Retirement plan with up to a 10% match of your base gross compensation Tuition reimbursement opportunities & professional development Volunteer opportunities -and earn additional PTO hours! On-site clinics for Vaccines and Mammograms And many more! Come join GECU as we are a curated culture of respect, understanding, and mutual recognition. We believe forming bonds and connecting with each other only stands to strengthen the service we provide to our members in our mission of improving the Quality of Financial lives! General Electric Credit Union is an Equal Opportunity Employer
    $59k-72k yearly est. 11d ago
  • Laboratory Quality Assurance (QA) Associate

    Medpace 4.5company rating

    Quality assurance specialist job in Cincinnati, OH

    The successful candidate will be responsible for facilitating the management of sponsor audits, and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders. Responsibilities * Facilitating Medpace sponsor audits onsite; * Review and assess responses to sponsor audit reports; * Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits; * Provide guidance to Medpace study teams during sponsor audits; and * Manage pre-inspection activities for Medpace inspections. Qualifications * Bachelor's degree in life science or a related field; * Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA); * Strong communication skills; * Strong quality mindset; * Excellent written and verbal communications skills; * Independent thinking and planning ability; * Experience with a wide range of computerized systems; * Good time management skills; * Ability to switch between both big picture view and attention to detail; * The ability to work well on a team as well as independently. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $48k-69k yearly est. Auto-Apply 2d ago
  • Technical Documentation Specialist

    3dB Labs

    Quality assurance specialist job in Olde West Chester, OH

    Job DescriptionThe Technical Documentation Specialist is responsible for owning and producing all end-user manuals, technical guides, and product documentation across 3dB Labs' hardware and software portfolio-including SCEPTRE, Kirby, Citadel, and associated turnkey DSP systems. Unlike a traditional tech-writer role, this position requires a DSP-literate professional who can understand signal processing workflows, radio operations, and the operational CONOPS our systems support. Through training with our Product, Field, and QA teams, this role will develop a deep understanding of how customers use our capabilities (DoD, SOF, IC, and partner organizations) and independently translate that knowledge into clear, accurate, and mission-relevant documentation. The Technical Documentation Specialist works closely with Product Management, Software Engineering, and Field Applications to capture authoritative product behavior and operational detail, and partners with Marketing to ensure documentation is visually consistent with 3dB branding.Key Responsibilities Documentation Ownership & Creation Develop, write, and maintain user manuals, quick-start guides, release-specific documentation, and system reference materials for all 3dB Labs products. Translate complex DSP workflows, radio integration steps, and mission CONOPS into clear, intuitive documentation that reflects real-world usage. Own the documentation pipeline for each product release-planning, drafting, reviewing, and publishing content with minimal reliance on Field Team inputs. Convert all existing Word-based manuals into modern Markdown-based documentation (with training provided on internal tooling). Technical Expertise & Product Familiarity Learn and master SCEPTRE's core mission areas, workflows, and advanced features, including geolocation, collection, and multi-node operations. Learn Kirby and Citadel operations at a functional depth, including setup, configuration, general troubleshooting, and mission use cases. Understand common customer operational environments and the “why” behind product workflows. Cross-Team Collaboration Work with the Product Team and QA to ensure documentation aligns with accepted requirements, release content, and expected behavior. Collaborate with Field Applications to validate use-case accuracy (not to write the content for you-just to verify authenticity). Partner with Marketing to ensure layout, style, and branding consistency across all documentation. Quality & Version Control Maintain a documentation versioning structure that aligns with software releases. Ensure all manuals meet high standards for technical accuracy, clarity, and consistency. Establish a repeatable process for gathering updates each release cycle with minimal burden on engineering or field personnel. Qualifications Required Background in DSP, SIGINT, EW, RF systems, or similar technical domain-professional, military, academic, or equivalent experience. Ability to learn complex hardware/software products (e.g., SCEPTRE-like systems) with minimal hand-holding. Strong writing and communication skills with a demonstrated ability to explain technical concepts clearly. Proficiency with or willingness to learn Markdown, Git, and documentation toolchains. Comfort working with multidisciplinary teams across engineering, product, field operations, and marketing. Active government clearance or the ability to obtain one. Preferred Experience documenting military, IC, or commercial SIGINT/DSP systems. Hands-on experience with SDRs, RF equipment, or geolocation software. Familiarity with software release processes and version-controlled documentation repositories. Powered by JazzHR k8q7mvJPEK
    $32k-54k yearly est. 23d ago
  • Consumer Documentation Specialist (Document Specialist) (4656-12)

    Hamilton County (Oh 2.9company rating

    Quality assurance specialist job in Cincinnati, OH

    Be part of our Team! We are committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, genetic information, protected veteran status, gender identity or expression, sexual orientation or any other characteristic protected by law. We are a second-chance employer and a recovery friendly workplace. Highly Competitive Employee Benefits Package and Generous Paid Time Off 11 Paid Holidays, Immediately Begin with 40 hours Paid Vacation if No Prior Service. Ohio Public Employee Retirement System which includes 14% Employer Contribution AND a defined benefit option. Highly Competitive and Comprehensive Benefits Package: Medical, HRA, Dental, Vision, Employer-Paid Life Insurance, Long-Term Disability, Tuition Reimbursement, Paid Parental Leave, Public Service Loan Forgiveness Eligibility, Commuter Stipend or Free On-Site Parking, Wellness Incentives, robust Employee Assistance Program, access to Free Medical and Rx through Marathon Health, plus expansive Behavioral and Mental Health Resources, and More! DEADLINE TO APPLY: 1/26/2026 WORK LOCATION: Job & Family Services 222 E. Central Parkway Cincinnati, OH 45202 WORK HOURS: Full time 40 hours weekly SALARY: $19.03 hrly NOTE: Applicants for positions with Hamilton County Job and Family Services are subject to background screening in accordance with the document: "Offenses that May Disqualify Candidates for Employment." Convictions from this list may disqualify a candidate for employment with HCJFS. Applicants for Children's Services positions cannot provide foster care for children in the custody of Hamilton County. REQUIREMENTS (EDUCATION, EXPERIENCE, LICENSURE, CERTIFICATION): Ability to calculate fractions, decimals and percentages and to read and write common vocabulary. One (1) course in office practice and procedures. Or month experience Or equivalent ESSENTIAL JOB FACTORS: Must be able to lift 50 pounds and stand for long periods, bend, and stretch to do the work. Must maintain a valid driver's license issued by the state of residency and required auto liability insurance. REGULAR AND PUNCTUAL ATTENDANCE IS REQUIRED TO PERFORM THE FOLLOWING ESSENTIAL FUNCTIONS: File Room Duties Handle all case record material of a highly confidential nature on all consumers (active or closed) for all divisions. File materials according to divisional protocols. Pull records for Federal, State or County auditors. Pull records for agency and authorized County Personnel. Utilize the State & Local computer applications (including but not limited to CRIS -E/SETS/SACWIS/ CDTS ) for research, record tracking, and label/file manufacture. Researches records to determine retention status. Shifts large volumes of case records. Assists staff with microfilm research or document imaging duties. Prepares case records for computer imaging. Operates high speed scanner for computer imaging of documents. "Index" (assign category) case records scanned into document imaging system. Box/log out/label imaged records for storage/disposal. Assists with inventory control at the off-site storage facility. Assists with delivery and pick-ups of records in the JFS buildings and at various county facilities. Maintains & provides statistical data as required. OTHER DUTIES AND RESPONSIBILITIES: Performs other related duties as assigned; participates in special projects. Attends and participates in training, workshops and meetings to enhance individual skills, knowledge and job performance. POSITIONS SUPERVISED: None KNOWLEDGE, SKILLS AND ABILITIES: (*Indicates developed after employment) Knowledge of: office practices and procedures; agency policies and regulations. Ability to: carry out detailed oral or written instructions; respond to correspondence or e-mails, complete routine forms; read, copy and record figures and other data accurately; accurately copy material from one record to another and recognize grammatical and spelling errors; gather, organize, collate and classify information; maintain accurate records; sort items into categories according to established methods; obtain basic information and/or answer routine inquiries from other agencies or the public over the phone or in person; create and/or maintain a file system and/or database; properly handle confidential information; use a CRT for information retrieval and/or update functions; properly use, resupply and perform very basic routine service/repairs on office copiers, printers or other office machines; work alone on most tasks while being able to work in concert with others as needed; place documents in sequential order, to communicate with tact and diplomacy, problem solve, identify/differentiate/categorize large numbers of similar/related document types. Skill in: operating agency network personal computer software and program operating systems*; preparing, scanning, indexing records using On-Base Document Imaging System. LICENSURE AND CERTIFICATION REQUIREMENTS: None BACKGROUND CHECKS REQUIRED: Background checks consistent with requirements in OAC 5101:2-5-09 must be completed at employment and every ten years following, including but not limited to the following systems: * State Automated Child Welfare Information System (SACWIS) * State Child/Abuse Neglect Central Registry Check for any state in which the applicant resided within the last ten years * Ohio Bureau of Criminal Identification Investigation (BCI) * FBI * National Sex Offender Public website (WWW.NSOPW.Gov) Code 5101:2-5-09 must be conducted for each prospective employee
    $19 hourly 1d ago
  • Quality Assurance (QA) Associate

    Medpace 4.5company rating

    Quality assurance specialist job in Cincinnati, OH

    The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders. Responsibilities * Facilitating Medpace sponsor audits onsite; * Review and assess responses to sponsor audit reports; * Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits; * Provide guidance to Medpace study teams during sponsor audits; * Manage pre-inspection activities for Medpace inspections; * Provide inspection data trends to the Quality Metrics group for executive management review; * Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents; * Conduct mock interviews for subject matter experts (SMEs) during inspection preparation; * Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk; * Act as QA lead for inspections at Medpace; * Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and * Maintain the memorializing of frequently asked questions repository for regulatory inspection. Qualifications * Bachelor's degree in science or a related field; * Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA); * Strong communication skills; * Strong quality mindset; * Experience in supporting or conducting audits; * Excellent written and verbal communications skills in English; * Independent thinking and planning ability; * Experience with a wide range of computerized systems; * Good time management skills; * Ability to switch between both big picture view and attention to detail; and * The ability to work well on a team as well as independently. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $48k-69k yearly est. Auto-Apply 2d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in West Carrollton, OH?

The average quality assurance specialist in West Carrollton, OH earns between $34,000 and $90,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in West Carrollton, OH

$56,000

What are the biggest employers of Quality Assurance Specialists in West Carrollton, OH?

The biggest employers of Quality Assurance Specialists in West Carrollton, OH are:
  1. Kettering Health Network
  2. Soin Medical Center
  3. Accelevation
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