Quality assurance specialist jobs in Kentucky - 163 jobs
Quality Auditor
Firstsource 4.0
Quality assurance specialist job in Louisville, KY
JD -Quality Auditor
Job Title- Certified Auditor
Schedule: 8am to 5 pm EST The Outpatient Coding Auditor is responsible for conducting detailed reviews of coded outpatient medical records to ensure coding accuracy, documentation compliance, and regulatory alignment. This includes validating CPT/HCPCS and ICD-10-CM codes assigned for emergency room, same-day surgery, observation, ancillary services, and outpatient clinic visits. The role ensures the hospital's outpatient coding practices are accurate, compliant, and aligned with payer rules and coding guidelines, ultimately supporting the revenue integrity of SRMC.
Key Responsibilities:
Coding Audit and Validation
* Review a sample of coded outpatient records including:
o Emergency Department (ED)
o Outpatient Surgery (Day Surgery)
o Observation cases
o Radiology and Laboratory services
o Outpatient Clinic encounters
* Validate CPT, HCPCS, and ICD-10-CM codes for diagnoses, procedures, and E/M levels.
* Ensure accuracy in modifier usage, code selection, and code sequencing.
* Confirm services are supported by clinical documentation and aligned with CMS Outpatient Prospective Payment System (OPPS) rules, NCCI edits, and payer policies.
* Identify coding errors including overcoding, undercoding, and missed codes, incorrect sequencing, and incorrect modifiers.
Documentation Review & Query Support
* Assess documentation for clarity, completeness, and compliance with coding requirements.
* Provide feedback to coders regarding missed opportunities or documentation improvement needs.
Compliance & Regulatory Oversight
* Ensure coding practices follow:
o AHA CPT Guidelines
o ICD-10-CM Official Guidelines for Coding and Reporting
o NCCI (National Correct Coding Initiative) edits
o Medicare/Medicaid and commercial payer rules
* Identify and escalate potential compliance risks including unbundling, modifier misuse, and billing conflicts.
Reporting & Education
* Prepare detailed audit findings reports summarizing results, trends, and recommendations.
* Deliver targeted education and training to outpatient coding staff based on audit findings.
* Track individual coder and team performance, providing ongoing coaching and resources.
* Collaborate with coding supervisors, trainers, and HIM leadership to implement corrective actions.
Qualifications:
* Required Certifications:
o CPC, CCS (AHIMA or AAPC credential required)
* Experience:
o 3+ years of hands-on outpatient coding experience in a U.S. hospital setting
o Prior experience with coding audits or quality assurance highly preferred
* Strong knowledge of:
o CPT, HCPCS, ICD-10-CM
o Modifier usage (e.g., -25, -59, -LT/RT, etc.)
o Outpatient reimbursement methodologies (e.g., APCs, OPPS)
o CCI edits and MUEs
* Familiarity with encoder software and EHR platforms (e.g., 3M, Epic, Cerner, TruCode)
* Strong analytical and communication skills
Performance Metrics:
* Audit Accuracy Standard: 95%
* Timeliness: Audit completion within defined SLA)
* Reporting: Timely delivery of audit summaries and feedback reports
* Education: Contribute to team training or knowledge sharing on a regular basis.
We are an Equal Opportunity Employer. All qualified applicants are considered for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by federal, state or local law.
$27k-33k yearly est. 1d ago
Looking for a job?
Let Zippia find it for you.
Software QA Specialist (December 2025 Grads)
Toyota Industries Commercial Finance 4.3
Quality assurance specialist job in Louisville, KY
Bastian Solutions is seeking Software QA Specialist who have graduated December 2025 or who will be graduating May 2026 to join our team in Louisville, KY or Noblesville, IN.
Are you interested in problem solving and debugging challenging software issues?
The Quality Assurance team is the primary proponent for all quality assurance programs affecting Bastian Software Solutions (BSS). The QA Specialist is integral in supporting the QA group to perform quality testing for existing, modified, and custom software to be implemented for BSS's clients, as well as leading other process improvement initiatives. This person manages the development of complete test plans as well as conducts quality, stress, regression and load tests for software programs developed at BSS and Bastian India. The QA Specialist will perform complete validation ensuring that all software modules meet functional specifications, software design documents, and end user requirements.
General Job Duties
Database Analysis. Performs backend database validation in Microsoft SQL Server or Oracle, including validating queries, updates, stored procedures, maintenance plans, data migration, and triggers.
Requirements Analysis. Analyzes project requirements from specifications, maps test cases to requirements and designs test coverage plan.
Test Case Management. Develops, documents, and maintains functional test cases and other test artifacts like test data, data validation, and automated scripts to validate all project requirements are fulfilled.
Test Plan Management. Holds and facilitates test plan/case reviews with cross-functional team members. Creates and executes User Acceptance Test plans with project team.
Software Testing. Executes and evaluates manual and automated test cases and records test results.
Issue Management. Identifies any potential quality issues per defined process and escalates high priority quality issues immediately to project team and management.
Defect Management. Isolates, replicates, documents, and reports root cause defects and verifies defect fixes.
Environment Management. Creates and maintains virtual machines for the customers whose programs are being tested. The analyst is responsible for maintaining synchronized environments and documenting changes.
Software Installation. Installs software promotes on test environments, performs needed configurations, and ensures that the program performs correctly. When called upon, may also help project managers to do the same thing in production environments.
Software Configuration. Understands the available configurations and is able to set and test appropriately for the project and test case being performed.
Travel Requirements
Up to 15% overnight travel to customer sites.
Requirements
Must be eligible to work in the USA long term without sponsorship.
Bachelor's Degree in Computer Science, Engineering, Computer Information Systems, or related degree.
Experience using Microsoft SQL
Previous software quality assurance or software oriented internship or co-op experience
Strong analytical skills
Excellent problem solving capability (business and technical)
Excellent verbal and written communication skills
Enjoys working in the software development and automation technology field (very computer literate)
Strong quality control, quality assurance and computer skills including: TFS, manual and automated testing tools, and various Databases (SQL Server and Oracle).
To learn more about us, click here - ****************************
About Bastian
Bastian Solutions, a Toyota Advanced Logistics company, is an independent material handling and robotics system integrator providing automated solutions for distribution, manufacturing, and order fulfillment centers around the world. Our team specializes in consulting, system design, project management, maintenance, and installation, while sourcing the best equipment and automation technology. We take great pride in providing exceptional service and flexibility to our customers.
In addition to exciting work at a growing company, we offer the following benefits:
Health, Dental, and Vision Insurance
401(k) Retirement Plan with a company match
Vacation/Holiday Pay
Tuition Reimbursement
Flexible Work Schedules
Volunteer Work
Professional Associations, Conferences and Subscriptions
Company Meetings & Events
Bastian Solutions does not work with outside recruiting agencies. No solicitation phone calls please.
$42k-70k yearly est. 1d ago
Software QA Professional
Bastian Material Handling
Quality assurance specialist job in Louisville, KY
Bastian Solutions is seeking a Software QA Professional to create and execute test plans on custom developed software. This person will work in either Louisville, KY or the new headquarters in Noblesville, IN. The Quality Assurance team is the primary proponent for all quality assurance programs affecting Bastian Software Solutions (BSS). The QA Professional is integral in supporting the QA group to perform quality testing for existing, modified, and custom software to be implemented for BSS's clients, as well as leading other process improvement initiatives. This person manages the development of complete test plans as well as conducts quality, stress, regression and load tests for software programs developed at BSS and Bastian India. The QA Professional will oversee or perform complete validation ensuring that all software modules meet functional specifications, software design documents, and end user requirements.
Job Functions
* Database Analysis. Performs backend database validation in Microsoft SQL Server or Oracle, including validating queries, updates, stored procedures, maintenance plans, data migration, and triggers.
* Requirements Analysis. Analyzes project requirements from specifications, maps test cases to requirements and designs test coverage plan.
* Test Case Management. Develops, documents, and maintains functional test cases and other test artifacts like test data, data validation, and automated scripts to validate all project requirements are fulfilled.
* Test Plan Management. Holds and facilitates test plan/case reviews with cross-functional team members. Creates and executes User Acceptance Test plans with project team.
* Software Testing. Executes and evaluates manual and automated test cases and records test results.
* Issue Management. Identifies any potential quality issues per defined process and escalates high priority quality issues immediately to project team and management.
* Defect Management. Isolates, replicates, documents, and reports root cause defects and verifies defect fixes.
* Environment Management. Creates and maintains virtual machines for the customers whose programs are being tested. The analyst is responsible for maintaining synchronized environments and documenting changes.
* Software Installation. Installs software promotes on test environments, performs needed configurations, and ensures that the program performs correctly. When called upon, may also help project managers to do the same thing in production environments.
* Software Configuration. Understands the available configurations and is able to set and test appropriately for the project and test case being performed.
Travel Requirements
* 15% overnight travel (Travel expenses paid by Bastian Solutions)
* Must maintain a valid driver's license
Preferred Skills and Required Qualifications
* Must be eligible to work in the USA long term without sponsorship.
* Bachelor's Degree in Computer Science, Engineering, or related field.
* 2+ years of relevant QA technical experience
* Ability to write and execute SQL Queries
* Ability to manipulate data in a SQL database
* Previous experience writing test cases
* Troubleshooting knowledge with custom software
* Excellent problem solving capability (business and technical)
* Enjoys working in the software development and automation technology field (very computer literate)
* Strong quality control, quality assurance and computer skills including: TFS, manual and automated testing tools, and various Databases (SQL Server and Oracle).
To learn more about us, click the following link - *******************************************
About Bastian
Bastian Solutions, a Toyota Advanced Logistics company, is an independent material handling and robotics system integrator providing automated solutions for distribution, manufacturing, and order fulfillment centers around the world. Our team specializes in consulting, system design, project management, maintenance, and installation, while sourcing the best equipment and automation technology. We take great pride in providing exceptional service and flexibility to our customers.
In addition to exciting work at a growing company, we offer the following benefits:
* Health, Dental, and Vision Insurance
* 401(k) Retirement Plan with a company match
* Vacation/Holiday Pay
* Tuition Reimbursement
* Flexible Work Schedules
* Volunteer Work
* Professional Associations, Conferences and Subscriptions
* Company Meetings & Events
Bastian Solutions does not work outside recruiting agencies. No solicitation phone calls please.
$38k-64k yearly est. 60d+ ago
Manufacturing Quality Assurance Specialist
Piramal Enterprises Ltd.
Quality assurance specialist job in Lexington, KY
Business: Pharma Solutions Department: Quality Assurance
The primary purpose of the role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).
Reporting Structure
This position reports to the Quality Assurance Supervisors
Shift
Night Shift
Key Responsibilities:
• Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
• Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP's.
• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
• Sampling and lab testing of the utilities including water, steam, and compressed gases.
• Perform plate enumeration and documentation of the results.
• Assist in the performance and documentation for cleaning verification sample collection and analysis.
• Participates in audits and involve in onsite client interactions as needed by management.
• Maintain laboratory instrumentation required for testing including calibrations.
• Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
• Participate in Microbiology material inventory control for EM media plates.
• Prepare and summarize data associate with site metrics, write, read, and revise SOP's QA and EM, technical reports.
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
• Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.
QUALIFICATIONS:
• Bachelor's Degree in physical or biological sciences or related scientific field preferred
• 1 years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
• Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
• Demonstrated ability to effectively communicate both verbally and in writing
• Ability to read and follow written instructions
• Detail oriented
• Understanding of sterile manufacturing preferred
• Technical writing skills preferred
$39k-65k yearly est. Auto-Apply 6d ago
Manufacturing Quality Assurance Specialist - Second Shift
Kindeva
Quality assurance specialist job in Lexington, KY
Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of controlled Current Good Manufacturing Practices (cGMP) documentation and manufacturing records, including any deviations or Out-of-Specification (OOS) results that may have occurred during lot production. Participates in the release of raw materials, intermediates, and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities, and keeps management informed on quality issues.
Responsibilities:
Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line clearances.
Supports the development and maintenance of Quality Systems as appropriate.
Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
Advises senior management on findings and recommendations related to internal and external auditing.
Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards. Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
Reviews and approves cGMP documentation, including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Reviews and approves product complaint investigations and assists with investigations.
Performs activities associated with various one-time or ongoing projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (Good Practice [GxP], 21 Code of Federal Regulations [CFR] Part 11, etc.).
Supports regulatory inspections and customer audits. Assists the Manager with daily and project activities as needed.
Performs other duties as assigned.
Qualifications:
Bachelor's degree in a scientific discipline. At least 3 years of Pharmaceutical/Medical Device cGMP quality experience.
Knowledge of data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available [ALCOA+]) and compliance with 21 CFR Part 11 for electronic records.
Knowledge of High-Performance Liquid Chromatography (HPLC) principles and the ability to review data for accuracy and completeness.
Knowledge of microbiological testing principles and the ability to review data for accuracy and completeness.
Ability to assess problems, to identify solutions, to plan and implement necessary changes.
Experience in quality systems auditing (internal and/or external) preferred.
Familiarity with electronic Quality Management System (QMS) platforms (e.g., TrackWise, MasterControl, etc.).
Experience in manufacturing aseptically filled, sterile products preferred.
Advanced knowledge of cGMP regulations and validation principles (e.g., FDA 21 CFR Part 820, International Organization for Standardization [ISO] 13485, etc.).
Ability to work well in a team-oriented environment.
Well-developed communication and technical writing skills.
Qualified to work with controlled substances.
Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.
Physical Requirements:
Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus to read/understand/execute documentation as required by the position
Employees are required to follow all cGMP and safety procedures.
Employee is required to regularly use their hands in order to handle materials and supplies.
Employee is required to regularly use their hands in order to handle materials and supplies.
Employee is required to effectively use communication by both telephone and electronic means.
Employee is required to regularly stand and walk for extended periods of time.
The employee must wear all required safety equipment and safely perform assigned work.
Employees must use proper lifting techniques and be conscious of hazards around him/her.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 25 pounds.
# LI-Onsite
$39k-65k yearly est. 10d ago
Senior Manager , Inventory Control and Quality Assurance
Shipmonk Fulfillment Careers 4.2
Quality assurance specialist job in Louisville, KY
Job Description
About ShipMonk
ShipMonk isn't just a 3PL; we're a growth partner for merchants. We provide cutting-edge technology and a network of owned and operated fulfillment centers that empower high-growth ecommerce and DTC brands to stress less and grow more. With over 2,500 employees across five countries, we're on a mission to revolutionize fulfillment by providing everything from the fastest click-to-delivery and real-time inventory to custom solutions-all with a merchant-first mindset.
Why ShipMonk?
We believe in building for the long term, and our success is powered by five key differentiators that help us become true partners to our merchants.
● Global Fulfillment Network: Our 12+ owned and operated fulfillment centers span the US, Canada, Mexico, the U.K., and Mainland Europe. We never outsource, ensuring quality and consistency.
● Proprietary Technology: We've eliminated the need for tribal knowledge with our AI-powered platform. It provides a real-time, unified view of inventory and orders, giving our merchants the control and visibility they need to succeed.
● Unrivaled Support: We provide hands-on, "mom and pop" support with a global reach. Our dedicated teams are on-site at every fulfillment center, ready to jump into action.
● Transparent Pricing: We believe in honest, long-term partnerships. Our all- inclusive pricing means predictable costs, with no hidden fees or surprises.
● Committed to the Future: We invest over $10 million annually in research and development to ensure our technology and services continually evolve, helping merchants plant roots with a partner who is here to stay.
Our Core Values
Our values are the heart of our culture. We're looking for individuals who embody these principles every day.
● Merchant-first: We handle the logistics so our merchants can focus on what they do best-growing their business.● Own it: We take ownership of our work, our mistakes, and our successes.
● People make ShipMonk: We believe in our team and invest in our people.
● Change the score: We challenge the status quo, constantly innovating and improving.
● Get sh*t done: We're a fast-paced, high-growth company that values action and results.
We are seeking a highly skilled and experienced Senior Manger to join the Inventory Control & Quality Assurance (ICQA) team at ShipMonk. As a member of the ICQA team, this role will be responsible for ensuring best-in-class levels of inventory control and operational quality across multiple ShipMonk fulfillment centers, ensuring data accuracy, process execution, and driving continuous improvement through hands-on participation in operations and generating actionable insights.
What you'll do:
Partner with local operations and Inventory Control leadership to drive best in class Inventory Control & Quality Assurance results, with multi-site responsibility.
Develop and implement inventory control strategies and processes to maintain optimal levels of inventory accuracy, process quality, and operational execution.
Analyze inventory/quality data and performance trends to identify areas for process- and/or execution-based improvement, driving through to the delivery of sustained performance and potential cost savings.
Design and generate new inventory control processes, reports, dashboards and metrics to provide insights into stock levels, trends and performance.
Utilize inventory management systems and technology to streamline processes and improve both data accuracy and quality.
Lead and support continuous improvement initiatives to enhance inventory management processes and optimize warehouse operations, both on-site and virtually across multiple locations.
What you'll need:
Bachelor's degree in supply chain management, industrial engineering, or a related field preferred but not required.
Minimum of 5 years of experience in e-commerce fulfillment operations, inventory management, process development and process optimization, preferably in a fulfillment center or distribution environment strongly preferred.
This is an onsite role at any one of our FC's.
Excellent analytical and problem-solving abilities with a detail-oriented mindset. With the ability to analyze data and generate actionable insights using analytical tools such as MS Excel, Google Sheets, Tableau, SQL etc.
Proficiency in SQL for data extraction and report generations preferred but not required.
Strong communication and interpersonal skills with the ability to collaborate effectively across departments and levels of the organization. This role will require working with and through local partners, throughout the organization.
Strong understanding of inventory control best practices, lean principles, and continuous improvement methodologies.
Ability to travel up to 20%
$67k-98k yearly est. 4d ago
Senior Specialist, Quality Assurance
Cardinal Health 4.4
Quality assurance specialist job in Louisville, KY
What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
Job Summary
The quality assurancespecialist (QAS) performs all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility. The facility manufactures two sterile liquid injection drugs, FDG and NaF, that are used for Positron Emission Tomography (PET) scans.
Responsibilities
* Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
* Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
* Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
* Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
* Engages and collaborates with operations department to drive quality system and CGMP requirements.
* Performs product release activities per CGMP requirements.
* Monitors CAPA in investigations and closes when completed or escalates (if necessary).
* Performs aseptic review of the site with operations and documents results.
* Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification
Schedule: 1:00am-9:00am Monday through Friday, 1 weekend per month.
Location: Louisville, KY
Qualifications
* 2-4 years of experience, preferred
* Bachelor's degree in related field, or equivalent work experience, preferred
* Proficiency with MS Excel and MS Word
* Interpersonal skills
* Attention to detail
* Prior experience working nightshift, preferred
* Prior experience maintaining a filing system, preferred
* Project management, preferred
* Prior experience in a cGMP environment, preferred
What is expected of you and others at this level
* Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
* Works on projects of moderate scope and complexity
* Identifies possible solutions to a variety of technical problems and takes action to resolve
* Applies judgment within defined parameters
* Receives general guidance and may receive more detailed instruction on new projects
* Work reviewed for sound reasoning and accuracy
Anticipated salary range: $68,500 - $88,020
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
* Medical, dental and vision coverage
* Paid time off plan
* Health savings account (HSA)
* 401k savings plan
* Access to wages before pay day with my FlexPay
* Flexible spending accounts (FSAs)
* Short- and long-term disability coverage
* Work-Life resources
* Paid parental leave
* Healthy lifestyle programs
Application window anticipated to close: 3/28/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
$68.5k-88k yearly Auto-Apply 31d ago
Quality Assurance Associate
VWR, Part of Avantor 4.8
Quality assurance specialist job in Paris, KY
The Opportunity:
Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Assurance Associate to optimize our Performance Materials organization.
This role is full-time, on-site in Paris KY where you will work 3 days on/ 2 off 6PM- 6AM within a 24/7: 365 operation.
If you have quality assurance experience - let's talk
Who you are:
Minimum Education:
Highschool/ GED
Experience (2+ years)
Quality (cGMP; ISO standard preferred).
Collaboration skills (MS Office)
Preferred Experience:
With Quality Assurance/Quality control/Operations in a regulated environment
Reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, or governmental regulations.
Writing reports and procedures.
Presenting information and responding to questions from groups of managers and clients/ customers.
How you will thrive and create an impact:
Under limited supervision the Quality Assurance Associate will be responsible for:
Observing cGMP good documentation practices.
Maintaining work activities to meet operational requirements.
Monitoring staff performance in accordance to established standards.
Mentoring less-experienced peers and assist supervisors.
Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule.
Monitoring the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders.
Issuance and reconciliation of equipment and room logbooks.
Conducting reconciliation, filing and archiving all quality-controlled records.
Storing completed documents in the appropriate data files and coordinating off-site document storage with third party as necessary.
Providing pre-run line clearance to manufacturing.
Consulting with document originators to resolve discrepancies.
Working closely with internal departments to ensure commitment to customer is met in a timely manner.
Providing batch record review support.
Writing and revising SOPs as part of process improvement initiatives or as needed to support the department.
Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management.
Participating and driving the quality and safety culture of the site.
Performs other duties as assigned
Apply today!
Environment
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product.
· Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
· A frequent volume of work and deadlines impose strain on routine basis.
· Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at ****************************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
$45k-66k yearly est. Auto-Apply 6d ago
Mailroom Quality Assurance Coordinator
Conduent 4.0
Quality assurance specialist job in Erlanger, KY
Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is noticed and valued every day.
**Mailroom Quality Assurance Coordinator**
**Location:** Onsite in Erlanger, KY
**Pay:** $16 an hour with shift differential, which may be below your state's minimum wage. Please take this into consideration when applying.
**Schedule:** Monday-Friday 3:00pm-11:00pm
**About the Mailroom Quality Assurance Coordinator role:**
We are seeking a dedicated and detail-oriented Mailroom Quality Assurance Coordinator to support our quality processes and help ensure client satisfaction and operational excellence. The ideal candidate is highly organized, has a strong understanding of standard operating procedures, and thrives in a fast-paced production environment.
**What You'll Do:**
- Ensure all print and mail tasks are executed in compliance with established Standard Operating Procedures (SOPs).
- Reprint and process damaged packages to ensure timely and accurate delivery to clients
- Perform random quality inspections on printed and packaged materials to verify compliance with quality standards.
- Maintain and verify the balance check log, ensuring all printed checks are accounted for and documented appropriately.
- Collaborate with team members to meet daily production goals and client service-level agreements.
- Report and document any errors, discrepancies, or equipment issues promptly.
**What We're Looking For:**
+ Excellent oral and written communication skills
+ Must be able to multi-task while maintaining accuracy
+ Attention to detail
+ Proficient math skills
+ Must be at least 18 years old and able to pass a criminal background check and drug screening
+ High school diploma or GED required
+ Comfortable using Microsoft Office (Word, Outlook, Excel)
+ Dependable and able to work full-time onsite
**Why You'll Love It Here:**
+ Full-time, stable employment (up to 40 hours/week)
+ Benefits start day one - health, dental, vision, and more
+ Growth and career advancement opportunities
+ Friendly, professional work environment
Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated salary range for this role is $16 an hour **.**
Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law.
For US applicants: People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded: click here to access or download the form (********************************************************************************************** . Complete the form and then email it as an attachment to ******************** . You may also click here to access Conduent's ADAAA Accommodation Policy (***************************************************************************************** .
$16 hourly 32d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Bowling Green, KY
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.
PT Quality Assurance
Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.
If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************
$41k-61k yearly est. 14d ago
Quality Assurance Senior Associate - (JP10386)
3 Key Consulting
Quality assurance specialist job in Louisville, KY
Employment Type: Contract Business Unit: International and Distribution Quality Duration: 2+ years (with likely extensions) Notes: Only qualified candidates, please.
Posting Date: 06/02/22
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
Perform routine Quality Assurance assessments of site operations and provide direct oversight.
Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
Represent the Quality Unit during audits and inspections as needed.
Support internal/external audits and inspections as part of the audit/inspection team as needed.
Perform additional duties as specified by management
Basic Qualifications:
Master's degree and 1 year of Quality experience
Bachelor's degree and 2 years of Quality experience OR
Associate's degree and 6 years of Quality experience OR
High school diploma / GED and 8 years of Quality experience
Preferred Qualifications:
Ability to interpret and apply cGMP and GDP
Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
Good written and oral communication
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
Self starter
Attention to detail
Good written and oral communication
** Regulated environment experience/ understanding of regulations **
Day to Day Responsibilities:
Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
Perform routine Quality Assurance assessments of site operations and provide direct oversight.
Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
Represent the Quality Unit during audits and inspections as needed.
Support internal/external audits and inspections as part of the audit/inspection team as needed.
Perform additional duties as specified by management
Red Flags:
Inconsistent work history
Candidate should have regulated environment experience/ understanding of regulations
Interview process:
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
$41k-61k yearly est. Easy Apply 60d+ ago
Quality Assurance
United Talent Staffing 3.8
Quality assurance specialist job in Shelbyville, KY
Job description United Talent is immediately hiring Quality Assurance Associates in Louisville, KYJob Responsibilities:
Conducting quality inspection of parts for a major company
Stacking the good parts on pallets
Placing the defected parts in a bin
Pay and Shift: 7 am - 3:30 pm Monday-Friday, $14 per hour Requirements:
Pass a background check and drug screen
Ability to stand entire shift
Steel toed shoes
Long pants
Lift up to 30 pounds
Perks and Benefits:
Referral Bonus(each referral you send that works 40 hours you will receive $80. When they work 100 hours, you will receive $200)
Weekly pay via direct deposit or pay card
Medical benefits available
How to apply: give us a call at (502) 390-2131 or text at (502) 206-4815 or apply directly at utalent.com. You can always come see us in person as well! Office hours are Monday - Friday 8am-5pm. Our address is 10013 Forest Green Blvd, Louisville KY 40223EEO
$21k-27k yearly est. 25d ago
Mailroom Quality Assurance Coordinator
The Mailroom Associate Role
Quality assurance specialist job in Erlanger, KY
Pay: $16 an hour with shift differential, which may be below your state's minimum wage. Please take this into consideration when applying. Schedule: Monday-Friday 3:00pm-11:00pm
About the Mailroom Quality Assurance Coordinator role:
We are seeking a dedicated and detail-oriented Mailroom Quality Assurance Coordinator to support our quality processes and help ensure client satisfaction and operational excellence. The ideal candidate is highly organized, has a strong understanding of standard operating procedures, and thrives in a fast-paced production environment.
What You'll Do:
• Ensure all print and mail tasks are executed in compliance with established Standard Operating Procedures (SOPs).
• Reprint and process damaged packages to ensure timely and accurate delivery to clients
• Perform random quality inspections on printed and packaged materials to verify compliance with quality standards.
• Maintain and verify the balance check log, ensuring all printed checks are accounted for and documented appropriately.
• Collaborate with team members to meet daily production goals and client service-level agreements.
• Report and document any errors, discrepancies, or equipment issues promptly.
What We're Looking For:
Excellent oral and written communication skills
Must be able to multi-task while maintaining accuracy
Attention to detail
Proficient math skills
Must be at least 18 years old and able to pass a criminal background check and drug screening
High school diploma or GED required
Comfortable using Microsoft Office (Word, Outlook, Excel)
Dependable and able to work full-time onsite
Why You'll Love It Here:
Full-time, stable employment (up to 40 hours/week)
Benefits start day one - health, dental, vision, and more
Growth and career advancement opportunities
Friendly, professional work environment
Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated salary range for this role is $16 an hour.
$16 hourly Auto-Apply 33d ago
Bilingual Quality Auditor
Firstsource 4.0
Quality assurance specialist job in Louisville, KY
The primary objective of this role is to evaluate and enhance associate performance by ensuring compliance with quality standards and service level agreements, in alignment with Firstsource's core values. The Quality Analyst will be responsible for conducting audits, generating and analyzing quality reports, identifying performance trends, and acting as a liaison for internal teams and clients. This individual will serve as a subject matter expert in processing knowledge, quality metrics, and improvement initiatives for the assigned unit.
Key Responsibilities:
Conduct detailed analysis of individual, team, and organizational quality performance metrics.
Perform regular audits, side-by-sides, coaching sessions, and development meetings to support associate improvement.
Maintain a repository of internal quality data to track trends and guide performance enhancement strategies.
Collaborate with other Quality Analysts to share updates, support content development, and maintain training materials.
Stay informed on industry trends and best practices in quality and employee development.
Contribute to the evolution of quality initiatives, including expanding scope, refining scoring methodologies, and updating guidelines.
Serve as a primary point of contact for quality-related client communications and inquiries.
Perform additional duties as assigned.
Skills and Competencies:
Strong understanding of contact center operations and commitment to service excellence.
Demonstrated success in quality monitoring and performance improvement.
Skilled in identifying process inefficiencies and agent performance gaps.
Exceptional verbal, written, and presentation skills, including the ability to deliver feedback constructively and confidentially.
Highly organized, detail-oriented, and capable of managing multiple priorities.
Effective in remote mentoring and coaching environments.
Bilingual (English/Spanish) with the ability to audit, coach, and deliver feedback in both languages.
Qualifications:
Bachelor's degree in a related field (education, communication, business) or equivalent experience preferred.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Outlook, Word) required.
2 years of experience in an international contact center; quality experience required.
2 years of healthcare experience.
Fluency in Spanish and English required (written and verbal).
$27k-33k yearly est. 2d ago
Software QA Professional
Toyota Industries Commercial Finance 4.3
Quality assurance specialist job in Louisville, KY
Bastian Solutions is seeking a Software QA Professional to create and execute test plans on custom developed software. This person will work in either Louisville, KY or the new headquarters in Noblesville, IN.
The Quality Assurance team is the primary proponent for all quality assurance programs affecting Bastian Software Solutions (BSS). The QA Professional is integral in supporting the QA group to perform quality testing for existing, modified, and custom software to be implemented for BSS's clients, as well as leading other process improvement initiatives. This person manages the development of complete test plans as well as conducts quality, stress, regression and load tests for software programs developed at BSS and Bastian India. The QA Professional will oversee or perform complete validation ensuring that all software modules meet functional specifications, software design documents, and end user requirements.
Job Functions
Database Analysis. Performs backend database validation in Microsoft SQL Server or Oracle, including validating queries, updates, stored procedures, maintenance plans, data migration, and triggers.
Requirements Analysis. Analyzes project requirements from specifications, maps test cases to requirements and designs test coverage plan.
Test Case Management. Develops, documents, and maintains functional test cases and other test artifacts like test data, data validation, and automated scripts to validate all project requirements are fulfilled.
Test Plan Management. Holds and facilitates test plan/case reviews with cross-functional team members. Creates and executes User Acceptance Test plans with project team.
Software Testing. Executes and evaluates manual and automated test cases and records test results.
Issue Management. Identifies any potential quality issues per defined process and escalates high priority quality issues immediately to project team and management.
Defect Management. Isolates, replicates, documents, and reports root cause defects and verifies defect fixes.
Environment Management. Creates and maintains virtual machines for the customers whose programs are being tested. The analyst is responsible for maintaining synchronized environments and documenting changes.
Software Installation. Installs software promotes on test environments, performs needed configurations, and ensures that the program performs correctly. When called upon, may also help project managers to do the same thing in production environments.
Software Configuration. Understands the available configurations and is able to set and test appropriately for the project and test case being performed.
Travel Requirements
15% overnight travel (Travel expenses paid by Bastian Solutions)
Must maintain a valid driver's license
Preferred Skills and Required Qualifications
Must be eligible to work in the USA long term without sponsorship.
Bachelor's Degree in Computer Science, Engineering, or related field.
2+ years of relevant QA technical experience
Ability to write and execute SQL Queries
Ability to manipulate data in a SQL database
Previous experience writing test cases
Troubleshooting knowledge with custom software
Excellent problem solving capability (business and technical)
Enjoys working in the software development and automation technology field (very computer literate)
Strong quality control, quality assurance and computer skills including: TFS, manual and automated testing tools, and various Databases (SQL Server and Oracle).
To learn more about us, click the following link
- *******************************************
About Bastian
Bastian Solutions, a Toyota Advanced Logistics company, is an independent material handling and robotics system integrator providing automated solutions for distribution, manufacturing, and order fulfillment centers around the world. Our team specializes in consulting, system design, project management, maintenance, and installation, while sourcing the best equipment and automation technology. We take great pride in providing exceptional service and flexibility to our customers.
In addition to exciting work at a growing company, we offer the following benefits:
Health, Dental, and Vision Insurance
401(k) Retirement Plan with a company match
Vacation/Holiday Pay
Tuition Reimbursement
Flexible Work Schedules
Volunteer Work
Professional Associations, Conferences and Subscriptions
Company Meetings & Events
Bastian Solutions does not work outside recruiting agencies. No solicitation phone calls please.
$42k-70k yearly est. 1d ago
Software QA Specialist (December 2025 Grads)
Bastian Material Handling
Quality assurance specialist job in Louisville, KY
Bastian Solutions is seeking Software QA Specialist who have graduated December 2025 or who will be graduating May 2026 to join our team in Louisville, KY or Noblesville, IN. Are you interested in problem solving and debugging challenging software issues?
The Quality Assurance team is the primary proponent for all quality assurance programs affecting Bastian Software Solutions (BSS). The QA Specialist is integral in supporting the QA group to perform quality testing for existing, modified, and custom software to be implemented for BSS's clients, as well as leading other process improvement initiatives. This person manages the development of complete test plans as well as conducts quality, stress, regression and load tests for software programs developed at BSS and Bastian India. The QA Specialist will perform complete validation ensuring that all software modules meet functional specifications, software design documents, and end user requirements.
General Job Duties
* Database Analysis. Performs backend database validation in Microsoft SQL Server or Oracle, including validating queries, updates, stored procedures, maintenance plans, data migration, and triggers.
* Requirements Analysis. Analyzes project requirements from specifications, maps test cases to requirements and designs test coverage plan.
* Test Case Management. Develops, documents, and maintains functional test cases and other test artifacts like test data, data validation, and automated scripts to validate all project requirements are fulfilled.
* Test Plan Management. Holds and facilitates test plan/case reviews with cross-functional team members. Creates and executes User Acceptance Test plans with project team.
* Software Testing. Executes and evaluates manual and automated test cases and records test results.
* Issue Management. Identifies any potential quality issues per defined process and escalates high priority quality issues immediately to project team and management.
* Defect Management. Isolates, replicates, documents, and reports root cause defects and verifies defect fixes.
* Environment Management. Creates and maintains virtual machines for the customers whose programs are being tested. The analyst is responsible for maintaining synchronized environments and documenting changes.
* Software Installation. Installs software promotes on test environments, performs needed configurations, and ensures that the program performs correctly. When called upon, may also help project managers to do the same thing in production environments.
* Software Configuration. Understands the available configurations and is able to set and test appropriately for the project and test case being performed.
Travel Requirements
* Up to 15% overnight travel to customer sites.
Requirements
* Must be eligible to work in the USA long term without sponsorship.
* Bachelor's Degree in Computer Science, Engineering, Computer Information Systems, or related degree.
* Experience using Microsoft SQL
* Previous software quality assurance or software oriented internship or co-op experience
* Strong analytical skills
* Excellent problem solving capability (business and technical)
* Excellent verbal and written communication skills
* Enjoys working in the software development and automation technology field (very computer literate)
* Strong quality control, quality assurance and computer skills including: TFS, manual and automated testing tools, and various Databases (SQL Server and Oracle).
To learn more about us, click here - ****************************
About Bastian
Bastian Solutions, a Toyota Advanced Logistics company, is an independent material handling and robotics system integrator providing automated solutions for distribution, manufacturing, and order fulfillment centers around the world. Our team specializes in consulting, system design, project management, maintenance, and installation, while sourcing the best equipment and automation technology. We take great pride in providing exceptional service and flexibility to our customers.
In addition to exciting work at a growing company, we offer the following benefits:
* Health, Dental, and Vision Insurance
* 401(k) Retirement Plan with a company match
* Vacation/Holiday Pay
* Tuition Reimbursement
* Flexible Work Schedules
* Volunteer Work
* Professional Associations, Conferences and Subscriptions
* Company Meetings & Events
Bastian Solutions does not work with outside recruiting agencies. No solicitation phone calls please.
$38k-64k yearly est. 12d ago
Quality Assurance Specialist I
Kindeva
Quality assurance specialist job in Lexington, KY
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: As a Quality Assurance (QA) Specialist I, you will provide critical oversight and support of pharmaceutical manufacturing operations providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production. Participates during the release of raw materials, intermediates and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.
Role Responsibilities
Supports on-shift manufacturing operations and activities including but not limited to real time auditing of production batch records, sampling and AQL, line clearances.
Supports the development and maintenance of Quality Systems as appropriate.
Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
Advises senior management on findings and recommendations related to internal and external auditing.
Manages deviation, OOS, CAPA and Change Control Systems:
Evaluate proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
Participate in investigations and root cause analyses for deviations, OOS results, and audit findings.
Ensure timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
Reviews, and approves cGMP documentation including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Reviews and approves product complaint investigations and assists with investigations.
Performs activities associated with various one-time or on-going projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
Supports regulatory inspections and customer audits.
Assists Manager with daily and project activities as needed.
Other duties as assigned.
Basic Qualifications
Bachelor degree in a scientific discipline (preferred experience may be substituted for education)
At least 0-3 years Pharmaceutical/Medical Device cGMP quality experience
Knowledge of data integrity principles (ALCOA+) and compliance with 21 CFR Part 11 for electronic records
Knowledge of HPLC principles and ability to review data for accuracy and completeness
Knowledge of microbiological testing principles and ability to review data for accuracy and completeness
Ability to assess problems, to identify solutions, to plan and implement necessary changes
Experience in quality systems auditing (internal and/or external) preferred
Familiarity with electronic QMS platforms (e.g., TrackWise, MasterControl,etc).
Experience in manufacturing aseptically filled, sterile products preferred
Advanced knowledge of cGMP regulations and validation principles (e.g. FDA 21 CFR Part 820, ISO 13485, etc)
Ability to work well in a team-oriented environment
Well-developed communication and technical writing skills
Qualified to work with controlled substances
Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.
Physical Requirements and Work Environment
Employee is required to regularly use hands in order to handle materials and supplies.
Employee is required to use computers for an extended period each day.
Employee is required to effectively use communication by both telephone and electronic.
Employee is required to regularly stand and walk for extended periods of time.
Employee must occasionally lift and or move up to 25 pounds.
Ability to use proper lifting techniques and be conscious of the work area hazards.
Employee is required to follow all site safety procedures.
#LI-Onsite
$39k-65k yearly est. 1d ago
Manufacturing Quality Assurance Specialist
Piramal Enterprises Ltd.
Quality assurance specialist job in Lexington, KY
Business: Pharma Solutions Department: Quality Assurance The primary purpose of the role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).
Reporting Structure
This position reports to the Quality Assurance Supervisors
Shift
Night Shift
Key Responsibilities:
* Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
* Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP's.
* Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
* Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
* Sampling and lab testing of the utilities including water, steam, and compressed gases.
* Perform plate enumeration and documentation of the results.
* Assist in the performance and documentation for cleaning verification sample collection and analysis.
* Participates in audits and involve in onsite client interactions as needed by management.
* Maintain laboratory instrumentation required for testing including calibrations.
* Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
* Participate in Microbiology material inventory control for EM media plates.
* Prepare and summarize data associate with site metrics, write, read, and revise SOP's QA and EM, technical reports.
* Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
* Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.
QUALIFICATIONS:
* Bachelor's Degree in physical or biological sciences or related scientific field preferred
* 1 years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
* Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
* Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
* Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
* Demonstrated ability to effectively communicate both verbally and in writing
* Ability to read and follow written instructions
* Detail oriented
* Understanding of sterile manufacturing preferred
* Technical writing skills preferred
$39k-65k yearly est. Auto-Apply 6d ago
Mailroom Quality Assurance Coordinator
Conduent Incorporated 4.0
Quality assurance specialist job in Erlanger, KY
Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is noticed and valued every day.
Mailroom Quality Assurance Coordinator
Location: Onsite in Erlanger, KY
Pay: $16 an hour with shift differential, which may be below your state's minimum wage. Please take this into consideration when applying.
Schedule: Monday-Friday 3:00pm-11:00pm
About the Mailroom Quality Assurance Coordinator role:
We are seeking a dedicated and detail-oriented Mailroom Quality Assurance Coordinator to support our quality processes and help ensure client satisfaction and operational excellence. The ideal candidate is highly organized, has a strong understanding of standard operating procedures, and thrives in a fast-paced production environment.
What You'll Do:
* Ensure all print and mail tasks are executed in compliance with established Standard Operating Procedures (SOPs).
* Reprint and process damaged packages to ensure timely and accurate delivery to clients
* Perform random quality inspections on printed and packaged materials to verify compliance with quality standards.
* Maintain and verify the balance check log, ensuring all printed checks are accounted for and documented appropriately.
* Collaborate with team members to meet daily production goals and client service-level agreements.
* Report and document any errors, discrepancies, or equipment issues promptly.
What We're Looking For:
* Excellent oral and written communication skills
* Must be able to multi-task while maintaining accuracy
* Attention to detail
* Proficient math skills
* Must be at least 18 years old and able to pass a criminal background check and drug screening
* High school diploma or GED required
* Comfortable using Microsoft Office (Word, Outlook, Excel)
* Dependable and able to work full-time onsite
Why You'll Love It Here:
* Full-time, stable employment (up to 40 hours/week)
* Benefits start day one - health, dental, vision, and more
* Growth and career advancement opportunities
* Friendly, professional work environment
Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated salary range for this role is $16 an hour.
Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law.
For US applicants: People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded: click here to access or download the form. Complete the form and then email it as an attachment to ********************. You may also click here to access Conduent's ADAAA Accommodation Policy.
$16 hourly 18d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Lexington, KY
Duties and Responsibilities:
Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
Courteous and helpful to other associates
Sweep and clean floors on nights with no scheduled vendor services
Weekly cleaning of Produce, Market and Deli Departments
Clean and organize the store mop room
Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
Follow QA daily check list and sanitation standards set by Food Lion
Follow current Standard Practices regarding cleanup of Hazardous Waste product
Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
Understand and follow Food Safety and Workplace Safety guidelines and procedures
Observe and correct all unsafe conditions that could cause associate or customer accidents
Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
Ensure compliance with local, state and federal regulations
Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
Perform all other duties as assigned
Qualifications:
High school graduate or equivalent preferred
Excellent interpersonal, organizational, communication and customer service skills
Ability and willingness to learn multiple tasks and technical requirements of the job
Ability to use technical information to solve problems
Must meet minimum age requirements to perform specific job functions
Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
Ability to use computers and other communication systems required to perform job functions
Perform repetitive hand and arm motions
Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
Pull or push up to 75 lbs. on occasion
Stand 100% of the time, frequently walking short distances
Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
Meet established volume activity standards for the position
Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
Have sufficient visual ability to check ID cards, checks, invoices and other written documents
$41k-61k yearly est. 22d ago
Learn more about quality assurance specialist jobs