Quality assurance specialist jobs in Dayton, OH - 194 jobs
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Quality Assurance Specialist
Quality Assurance Manager
Quality Assurance Associate
Document Specialist
Quality Supervisor
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Regulatory Compliance Specialist
Quality Control Specialist
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. 2d ago
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Quality Supervisor
Central Transport 4.7
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 2d ago
Regulatory Document Compliance Specialist
Gold Medal Products Company 4.3
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. 4d ago
Senior Trade Compliance Specialist
Crown Equipment Corporation 4.8
Quality assurance specialist job in New Bremen, OH
Crown Equipment Corporation is a leading innovator in world-class forklift and material handling equipment and technology. As one of the world's largest lift truck manufacturers, we are committed to providing the customer with the safest, most efficient and ergonomic lift truck possible to lower their total cost of ownership.
Job Posting External
Job Duties
Trade Compliance Administration and Metrics -
Develop and create performance metrics for agents, brokers, forwarders, and internal departments. Complete, correct, and ensure accurate HTS and ECCN classifications and recordkeeping. Utilize regulatory knowledge to determine country of origin for Company produced materials and recommend marking for same. Investigate restricted party screening for recommendation to management or legal. Calculate and prepare US Customs reconciliation for submission. Submit electronic filings with US Government entities and CTPAT supply chain security program. Manage qualification process for FTA and programs including Buy American to certify and ensure appropriate and accurate recordkeeping. Author protests for submission to US Customs and Border Protection Agency for relevant import entries. Research product scope, qualification, or inclusion in programs including Antidumping and Countervailing duties, and Partner Government Agency entry filing.
Internal Audits and Report Results -
Conduct internal audits of classifications, origin, trade programs, policies, procedures, CTPAT Security Criteria and transactional documents to identify risks. Compile audit results, provide recommendations, and coordinate corrective action to completion. Ensure questions, concerns, and requests for support/help are addressed and documented. Prepare export license applications. Complete corrections to documents or entries and maintain audit trail.
Policies and Procedures -
Research laws, regulations, and best practices to support Company's trade compliance programs. Interface with Company's international locations and functions to ensure alignment of trade procedures. Assist the development and administration of trade compliance policies, procedures, and periodic management reviews. Develop and facilitate training to address specific functions for current or newly hired employees.
Leadership and Development -
Assist in developing and coaching team members. Provide leadership to Support and Specialist personnel as subject matter expert in department. Monitor educational courses in supply chain security and international trade to ensure Company personnel receive appropriate education and experience. Lead training sessions for Trade department and service providers.
Minimum Qualifications
5-7 years related experience
Bachelor's degree (Business or Supply Chain)
Non-degree (12+ years of related experience and high school diploma/GED)
Frequent travel & Frequent overnight stays (6-20%)
Preferred Qualifications
Possess US Customs Brokers License or obtain within a year of hire.
Experience with project management.
Good interpersonal skills, professionalism, leadership,management and customer service skills.
Able to organize conferences, speak in front of groups and provide educational classes on various topics.
Work as a contributing team member on cross-functional and global teams and successfully interact with various government agencies.
Work Authorization:
Crown will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas or who need sponsorship for work authorization now or in the future, are not eligible for hire.
No agency calls please.
Compensation and Benefits:
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
$84k-110k yearly est. 4d ago
Quality Assurance Manager I
DHL (Deutsche Post
Quality assurance specialist job in Vandalia, OH
The QA Manager I role has a national salary range of $85,000- $150,000. DHL Supply Chain offers multiple benefits including Medical, Dental, Vision, Prescription, Discounted Stock Purchase, General Bonus Plan and a generous PTO policy. Are you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?
Job Description
Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers . Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support global and cross-sector Quality and Regulatory initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems.
* Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
* Oversee the licenses, permits, and registrations process.
* Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management
* Ensure that systems and equipment are validated (if applicable) and change control processes maintained
* Hire, train, and develop quality associates.
* Monitor the training and development of site associates to ensure compliance to processes and regulations.
* Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
* Review and provide recommendations on regulatory, customer and 3rd party audits.
* Review and identify trends within the quality assurance metrics for the organization.
* Primary customer contact for QA related issues/initiatives as needed.
* Develop, distribute and maintain regular management reports
* Manage site suppliers and prepare, receive, and act on audits
* Provide Business Development support and represent DHL in customer events and meetings as required
Required Education and Experience
* Bachelor Degree or equivalent 4 years work experience, required
* Certification related to quality control, preferred
* 3+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
* 1+ years of supervisory or management experience, required
* Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
* Participation in successful standards organization registration in a complex environment
* Supervising or implementing quality control programs
* Knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
* Administrator of training in compliance to regulated standards
* People development
* People management
* Process development
* Sufficient computer application experience
* Strong written and verbal communication
* Data analysis experience
* Training and facilitation skills
* Self management
* Problem solving
* Project management
* Presenting
* Report creation
* Solution execution
Our Organization is an equal opportunity employer.
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$85k-150k yearly 6d ago
Quality Assurance Manager - Food Manufacturing
Bullseye Personnel
Quality assurance specialist job in Dayton, OH
My client is seeking a Quality Assurance Manager for their food manufacturing facility located in Dayton, OH.
This position is directly responsible for the day\-to\-day coordination and management of the company's Quality, Food Safety, and Product Regulatory needs and initiatives. They will lead all quality control and assurance systems that promotes customer satisfaction, foods safety and positively impacts the quality culture.
QA Manager Job responsibilities:
•Ensures compliance of SOP's, GMPs, Regulatory requirements and Company expectations
•Responsible for all aspects of Quality Assurance Department as it relates to plant operations. Provides leadership and professional development of direct reports, promoting open discussion and collaborative teamwork.
•Manages and directs staff responsible for product batch testing and other quality control testing of plant products.
•Leads and\/or participates in quality audits of the plant.
•Develops, maintains, and reports required operational information to management. Ensures all quality\-related information required for regulatory reviews and reporting is maintained by the plant.
•Initiate investigations of all specification results and process deviations.
•Ensures that all GMP and Safety standards are in Compliance.
•Handles customer feedback as it relates to quality issues, maintaining necessary records regarding resolutions. Meets with vendors, customers and quality representatives and other company staff to discuss and resolve quality issues.
•Keeps abreast of latest manufacturing technologies, systems, and quality practices. Maintains a comprehensive understanding of all products manufactured by the plant as well as the raw materials, packaging materials, and operations required in the manufacturing process including quality specifications and standards.
•Responds to urgent and emerging food safety and health issues; executing food safety and health strategic plan and initiative tasks.
•Oversee the hold and release of products.
•Schedule and oversee corrective action system. Perform follow\-up and support to appropriate teams to ensure adequate corrective actions are documented, implemented, and measured for effectiveness.
QA Manager
Desired skills and experience:
•2\-5 years food production\/ food manufacturing experience
•Experience managing and implementing QA, Food Safety or Product Regulatory initiatives
•Well versed in the areas of GMP, HACCP, FDA, and USDA requirements
•Excellent interpersonal and communications skills
CONTACT:
Chad Crow
(215)309\-1969
ccrow@bullseyepersonnel.com
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$74k-111k yearly est. 60d+ 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 AssuranceSpecialist - 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. 31d ago
QA/QC Manager (Project Based)
Baker Concrete Construction 4.5
Quality assurance specialist job in Cincinnati, OH
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.
Nearest Major Market: Cincinnati
$88k-120k yearly est. 54d ago
Quality Assurance Manager
Caruso USA
Quality assurance specialist job in Cincinnati, OH
Job Summary: The FSQA Manager will oversee all aspects of food safety and quality assurance in our facility. This role involves ensuring compliance with federal regulations, developing quality control processes, and leading a team to uphold the highest standards of food safety and quality. The This role has the overall accountability of ensuring the food safety system is properly written, validated, documented, and implemented as directed to ensure regulatory compliance and the production of safe, legal, quality products. Supervisory Responsibilities:
Hires and trains quality assurance staff.
Oversees the daily workflow and schedules of the department.
Conducts performance evaluations that are timely and constructive.
Handles corrective action and termination of employees in accordance with company policy.
Duties/Responsibilities: Ensure compliance with USDA, FDA, and other regulatory standards.
Stay updated on food safety regulations and industry best practices.
Develops and implements HACCP, Preventive Controls (FSMA) and Quality Assurance System following industry best practices and conforming to a company selected GFSI standard.
Verify and maintain compliance with USDA, FDA and other applicable federal, state, local, and organizational laws, regulations, guidelines, and policies.
Lead QA and Sanitation teams. Develops, tracks, and reports department KPIs.
Develops and implements process and procedures to monitor incoming raw materials, in-process, and finished products to ensure compliance to all regulatory, customer, and company requirements and specifications.
Develops, implements, and manages procedures and policies to ensure food safety compliance.
Oversee food safety and quality programs implementation and effectiveness including Cleaning and Sanitation, Environmental Monitoring, Pest Management, Equipment Calibration, Equipment Commissioning, and Internal Audit.
Participates in all audits to include leading the audits.
Facilitate compliance with and completion of third-party audits, identity preserved inspection and corresponding corrective action implementation.
Manage internal, customer and consumer quality and food safety complaints including trending, reporting and corrective actions.
Provide backup for quality team supervision. Including Hold Product, Product Testing, Material and Ingredient Quality, Pest Control and Scheduling
Support training activities throughout the organization towards food safety and quality compliance.
Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
Identifies and sets appropriate quality standards and parameters for products.
Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.
Coordinates and participates in product testing processes.
Identifies and analyzes food safety and quality issues and participates in the process for solutions.
Performs other duties as assigned.
Required Skills/Abilities:
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Strong supervisory and leadership skills.
Proficient with Microsoft Office Suite or related software.
Education and Experience:
Bachelor's degree in agriculture, Food Sciences, Biology, Chemistry and/ or related field or equivalent experience required.
Certified Preventative Controls Qualified Individual (PCQI) and Hazard Analysis and Critical Control Points (HACCP) preferred.
Two to five years of experience in a related field required with supervisory experience preferred.
Experience with SQF and/ BRC audits and requirements.
Physical Requirements and working conditions:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 50 pounds at times.
Must be able to quickly traverse manufacturing areas.
This position requires an employee to work within a cold, temperature-controlled environment for long periods of time.
This position requires the ability to stand, sit at a desk, and walk around the office and plant.
This position requires a transient schedule, with the possibility of night, weekend, holiday work and overtime necessary to meet the needs of production coverage.
$74k-110k yearly est. 21d ago
Quality Assurance Manager - On Site
Pharmalogic Holdings
Quality assurance specialist job in Cincinnati, OH
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 a Quality Assurance Manager!
If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.
Position Title: QA Manager (6 am to 2pm)
Role Summary:
As the site Quality Assurance Manager, 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 site QA is responsible for training documentation for the staff on QA related activities.
The site QA is the responsible person for FDA inspections at the site and is listed on the FDA filing and associated permits as applicable. 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 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.
Provide training to staff on QA activities and SOPs. Assure staff is qualified for assigned quality tasks with documentation of training and qualification.
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.
Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management.
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.
Conduct 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 3-5 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.
PharmaLogic offers a competitive compensation package and superior benefits.
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
Extended health care
Life insurance
On-site parking
Paid time off
Vision care
$74k-110k yearly est. Auto-Apply 5d ago
Quality Assurance Specialist
AAA Mid-Atlantic
Quality assurance specialist job in Cincinnati, OH
AAA Club Alliance is seeking a Quality AssuranceSpecialist 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 AssuranceSpecialist 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 7d ago
Quality Assurance Specialist
Global Channel Management
Quality assurance specialist job in Mason, OH
Quality AssuranceSpecialist needs claims , appeals , call center experience
Quality AssuranceSpecialist 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 AssuranceSpecialist 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
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 2d ago
Quality Assurance Associate
Hikma 3.7
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
Quality Control Specialist
General Electric Credit Union 4.8
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. 9d ago
Technical Documentation Specialist
Lancesoft 4.5
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 7d ago
Quality Assurance (QA) Associate
Medpace 4.5
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 55d 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 14d ago
Associate II, Quality Assurance
Resilience 4.4
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 6d ago
Technical Documentation Specialist
3dB Labs
Quality assurance specialist job in Olde West Chester, OH
The 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
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.
$32k-54k yearly est. Auto-Apply 20d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Dayton, OH?
The average quality assurance specialist in Dayton, OH earns between $35,000 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 Dayton, OH
$56,000
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