5,780 Assurance Specialist jobs in the United States
Quality Assurance Specialist
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We are looking for a dedicated Quality Assurance Specialist to join our team in Des Plaines, Illinois. This is a Contract position, offering an opportunity to apply your expertise in quality assurance and testing within a dynamic work environment. The role requires attention to detail, adaptability to a cold environment, and the ability to perform physical tasks.
Responsibilities:
- Conduct manual testing processes to ensure product quality and compliance with specifications.
- Able to work in a cold environment and testing food products
- Lift and move items weighing between 25 to 50 lbs as part of routine tasks.
- Communicate effectively to report findings and coordinate with team members.
- Tuesday through Saturday schedule 8am-5pm
Requirements - Proficiency in Selenium web browser automation tools.
- Experience with manual testing processes and quality assurance methodologies.
- Ability to lift and move objects weighing 25 to 50 lbs.
- Basic English communication skills, both written and spoken.
- Willingness to work in cold environments.
- Availability for morning shifts from Tuesday through Saturday.
- Strong attention to detail and problem-solving skills.
- Ability to work independently and as part of a team. TalentMatch®
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app ( and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( .
Quality Assurance Specialist

Posted 2 days ago
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Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.
Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including:
- Medical, vision and dental insurance
- Life and AD&D insurance
- Paid holidays
- PTO accrual
- and much more!
Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!
Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.
**JOB SUMMARY**
Responsible for promoting quality standards within the center and ensuring quality policies and procedures are followed by center personnel under the direction of the Quality Assurance Manager. Escalates any non-compliance that affects donor safety or plasma quality to Quality Management. Operates within the scope of EU Guidance on Good Manufacturing Practice (GMP) and FDA cGMP 21CFR.
**ESSENTIAL JOB FUNCTIONS**
Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.
**MAIN DUTIES AND RESPONSIBILITIES**
Core
+ Assists with review of manufacturing activities, determines if records are in compliance with SOP and regulatory requirements, and ensures corrective actions when appropriate.
+ Ensures plasma release and shipments meet specifications and requirements as defined by customers and in DCOPs. When necessary, authority to stop production and/or release of product.
+ Ensures general understanding of all applicable state and federal regulations as well as industry and corporate policies.
+ Reviews and investigates final shipment release deviations including accurate labeling and documentation of shipments.
+ Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.
+ Reviews compliance issues with appropriate staff and their supervisors.
+ Provides accurate reports of the facility's compliance to Quality Assurance Manager (QAM), Regional Manager and/or VP of QA/RA.
+ Assists in analyzing, tracking, and trending data and determining appropriate actions to improve trending.
+ Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.
+ Ensures correct documentation and computer use for archiving or backup, including donor files.
+ Ensures supplies and equipment are received, maintained, stored, and documented to meet quality regulations.
+ Reviews qualification, calibration and maintenance, repair and operation of equipment and documentation of use.
+ Ensures QC checks are performed on all units and cases of products stored and shipped by the center.
+ Ensures QC checks are performed as required and, in acceptable ranges, for controls and test reagents.
+ Encourages and participates in continuous quality improvement process.
+ Monitors, prepares, and submits epidemiological data for PPTA or in corporate required format(s).
+ Ensures all staff is trained and training completion maintained for documenting competency to perform all assigned tasks.
+ Assists QAM evaluating the following:
+ Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance.
+ Monitoring the recording and reporting of test results by reviewing work sheets, quality control records, preventive maintenance records, and other records and entries (both manual and automated).
+ Performing written tests to assess problem solving skills, knowledge of DCOPs, and theory.
+ Assesses performance using internal blind specimens and external proficiency test specimens.
+ Ensuring minimum acceptable scores, performance, and remedial measures identified to correct inadequate performance on competency evaluations which are documented and retained in personnel records.
+ Evaluating summaries to provide useful information to correct individual or group performance problems identified, if any.
+ Ensures CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.
**General**
Must be able to execute all terms and conditions set forth in the **KEDPLASMA** **Employee** **Handbook** , including, but not limited to:
+ Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace.
+ Comply with company Global Code of Conduct and company's policies and procedures and all the applicable regulations.
+ Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code.
+ Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager.
+ Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors.
+ Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services.
+ Complete all assigned tasks in a timely manner as instructed by supervisor/manager.
+ Adhere to work schedules in completing and performing assigned tasks.
+ Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage.
+ Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a calm environment.
+ Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest.
+ Treat donors, visitors, and co-workers with courtesy, respect, and dignity.
+ Perform any miscellaneous duties or work assignments, as required.
**PRIMARY CONTACTS**
+ Center Management, donors, employees, auditors, inspectors, vendors, corporate staff, and visitors.
**REQUIREMENTS**
**Education, Qualifications & Experience**
+ Bachelor's degree in life science or related field, preferred.
+ Minimum two years' experience in a plasma center preferred.
+ Minimum one-year experience in a regulated industry. cGMP experience, preferred.
+ Three to five years of working experience in a biomedical field preferred.
+ Knowledge of FDA and EU regulations and standards preferred.
**Physical Requirements**
Work is primarily light in nature, with exerting up to 25lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.
**Working Conditions**
+ Primarily inside with well-lighted and well-ventilated areas.
+ Exposure to Blood Borne Pathogens.
+ Periodic exposure to an environment with a temperature of -40°C for short periods of time.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.
Quality Assurance Specialist

Posted 2 days ago
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We are seeking a **Quality Assurance Specialist** to ensure our products and operations comply with all applicable U.S. federal, state, and local regulations. This role will play a critical part in bridging communication with our global headquarters, overseeing product compliance, import documentation, product quality-related customer claims (VOC), and regulatory audits. You will be a key contributor in maintaining operational excellence in a fast-growing beauty retail environment.
**What You'll Do**
+ Review and approve product documentation for store onboarding, including ingredient lists and label compliance in accordance with U.S. regulations
+ Evaluate claims, marketing materials, and packaging to ensure regulatory accuracy
+ Manage and investigate product quality-related customer claims (VOC), and lead response efforts for product recalls or regulatory inquiries (e.g., FDA, state agencies)
+ Ensure compliance of physical retail operations with local legal and regulatory standards
+ Provide training and guidance to store staff on compliance-related matters
+ Manage import documentation and respond to customs-related issues to ensure smooth clearance and delivery
+ Maintain regular communication with our global headquarters regarding product specifications, documentation, and compliance updates
+ Establish, maintain, and enhance compliance policies in accordance with U.S. federal and state regulatory requirements
+ Monitor changes in product regulations (e.g., MoCRA, FD&C Act) and proactively recommend necessary updates
+ Review supplier audit documentation and conduct on-site inspections when necessary to ensure manufacturing practices meet quality and regulatory standards
**Qualifications**
+ 5-10 years of experience in quality assurance, preferably in a U.S.-based beauty or personal care platform
+ Bachelor's degree or higher in a relevant field (e.g., Chemistry, Biotechnology, Life Sciences)
+ In-depth understanding of U.S. and international regulatory frameworks (FDA, ISO standards, etc.)
+ Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements
**Preferred Qualifications**
+ Experience working in quality assurance roles at major U.S. beauty retailers or platforms
+ Multilingual capabilities preferred
+ Experience with ISO 22716 certification or compliance (GMP for cosmetics)
+ Familiarity with cross-border operations and global supply chain regulatory challenges
**About the job**
**Location:** Los Angeles, CA
**Employment Type:** Full-time
**Pay Range:** $75,000 - $8,000/year + Eligible for annual performance-based bonus
**Benefits:** 401(k) with Company Match, Employee Discount Program, Lifestyle Allowance, Mobile Phone Plan Reimbursement, Comprehensive Health/Dental/Vision Insurance, Generous Paid Time Off, Flexible Work Hours, Wellness Days, Creative Days, Monthly Team Building Budget and more!
**Pay Details:** 75,000.00 to 98,000.00 per year
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance
Quality Assurance Specialist

Posted 2 days ago
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Job Description
**Location:** United States-Florida-Jacksonville
**Job Number:** 17498
Performs visual and electronic, electrical and mechanical inspection and testing of parts and products. Works to achieve minimum defect levels while improving overall quality and customer satisfaction levels.
**What you will be responsible for:**
+ Observes and monitors production operations for functioning, operation, and accuracy to verify adherence to functional specifications.
+ Ensures compliance with ISO and assigned governmental and divisional quality policies, programs, plans, and procedures and applies them consistently and accurately.
+ Audits work policies, practices, processes, records and documentation for compliance and makes corrections as required. Ensures compliance with governmental regulations.
+ Executes changes in methods, sampling techniques and control procedures and processes to ensure maximum quality for cost.
+ Coordinates with other departments, including operations, engineering, HR, accounting and sales to implement approved programs.
+ Prepares accurate and timely preparation of error and/or salvage reports. Makes recommendations to minimize such errors.
+ Continually works to achieve short-term and long-term quality objectives, goals and measurements.
+ Performs such individual assignments as supervisors and superiors may direct; establishes and maintains effective work relationships within the department, the corporation, and the community.
+ Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.
+ All other duties as assigned.
Qualifications:
**What you will need to be successful in this role:**
+ High School Diploma or GED
+ At least 3 years of related experience.
+ Aerospace industry experience is strongly preferred
+ ISO9001 experience is preferred
+ Ability to perform internal audits
**The rewards of your career at AAR go far beyond just your salary:**
+ Competitive salary
+ Comprehensive benefits package including medical, dental, and vision coverage.
+ 401(k) retirement plan with company match
+ Generous paid time off program
+ Professional development and career advancement opportunities
**Physical Demands/Work Environment:**
+ The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ While performing the duties of this job, the employee may be regularly required to sit, stand, bend, reach and move about the facility.
+ The environmental characteristic for this position is an office setting. Candidates should be able to adapt to a traditional business environment.
+ Must be able to lift and carry up to 30 pounds and comply with OSHA standards
#LI-LM1 #LI-Onsite
We are 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.
Quality Assurance Specialist

Posted 2 days ago
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Job Description
**Title: Quality Assurance Specialist**
**Location: Augusta, ME**
**100% Remote (Maine Resident Preferred)**
**General Job Information:**
The Quality Assurance (QA) Specialist conducts a range of monitoring, reporting, research, and surveillance activities to support the work of quality management activities. This position reviews records, triages incidents, creates reports, retrieves and processes data and completes related statistical reporting, monitors in-process work and coordinates with a variety of program and district staff. The individual works independently and as part of a team to perform the daily work of the team, conducts research and processes data from multiple electronic systems and programs into reports, assists in the development of policies and procedures, and supports other users in proper implementation.
**Knowledge, Skills and Certifications:**
+ Possess or quickly develop knowledge of applicable Medicaid, MaineCare, and Home and Community Based Services (HCBS) Waiver policies and regulation, both state and federal.
+ Understand Person-Centered Thinking and Planning.
+ Demonstrate a high level of critical thinking and customer service skills as well as excellent written and oral communication skills.
+ Demonstrate initiative to pursue tasks and assignments independently with the ability to research and assimilate information from multiple resources with minimal training and oversight.
+ Demonstrated experience with retrieving data from multiple systems and synthesizing it into reports
+ Work cooperatively with varied constituents, providers, and stakeholder groups as well as varied levels of management which may include OADS QA waiver specialists, OADS Resource Coordinators, staff from Division of Licensing and Certification and the Office of MaineCare Services.
+ Demonstrate excellent problem solving skills and initiative
+ Comfort with processing data in Excel, including the ability to apply formulas, formatting, and pivot tables
+ Functional experience with Microsoft Office Suite, including Teams, SharePoint, Word, Excel, PowerPoint, and Outlook
**Duties and Deliverable:**
Tasks include:
+ Conduct a range of monitoring and surveillance activities including review and triage of critical incidents and complaints
+ Collect, review, and assess data from multiple data systems, HCBS providers, and other sources as needed, to determine compliance and or create reports regarding the work of the OADS quality structures and system performance.
+ Development of reporting structures for tracking activities and compliance.
+ Use MS Excel, SharePoint, and other electronic tools to accurately record data, detect anomalies, and perform corrections.
+ Extract and process data from multiple system and create reports.
+ Participate in initiatives assigned to support the Department's and Office's goals and objectives as directed.
+ Provide excellent customer service in conducting all work.
+ Coordinate review activities across multiple program areas.
+ Participate in meetings as assigned.
**Schedule:**
This is a full time 40-hours per week telework position.
Compensation for roles at Staffing Solutions Organization LLC (SSO) varies depending on a wide array of factors including, but not limited to, the specific office location, role, skill set, and level of experience. As required by applicable law, SSO provides a reasonable range of compensation for this role. In addition, SSO provides a range of benefits for this role.
Applicants must be authorized to work in the U.S. This position is not eligible for work authorization sponsorship including H-1B sponsorship) by SSO. Under the federal laws relating to the F-1 STEM EAD program, SSO may be able to support a STEM EAD extension application at the sole discretion of your Designated School Official. This does not guarantee that any STEM EAD extension application will be approved.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. Staffing Solutions Organization LLC is an E-Verify participant.
**Job Details**
**Pay Type** **Hourly**
**Education Level** **Equivalent Experience**
**Telecommute Percentage** **100**
**Hiring Max Rate** **30 USD**
Quality Assurance Specialist

Posted 3 days ago
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Position Description
- Support the maintenance of and improvement to NPC quality programs.
- Lead or coordinate the development, improvement, and delivery of training programs to improve quality.
- Support management with the tracking of quality system metrics for adherence to organizational or department targets, and elevate issues, when necessary.
- Manage and direct formal responses to external audits, assessments, and surveillances.
- Lead causal analyses to address deficiencies identified through audits, assessments, and surveillances, as required.
- Prepare formal corrective action plans, in conjunction with appropriate functional organizations, to address causal factors identified through the causal analysis process.
- Maintain the approved internal audit, assessment, and surveillance schedule.
- Support and execute formal assessments and surveillances of key processes to assure a high level of compliance with the QA program and associated regulatory requirements.
- Facilitate implementation of performance improvement initiatives and actions taken as a result of audit, assessment, and surveillance corrective actions.
- Provide training to staff, as necessary.
- Other Quality Assurance duties, as assigned.
+ Knowledge and application of applicable nuclear codes and standards, including 10 CFR 830 Subpart A, Quality Assurance Requirements; DOE Order 414.1D, Quality Assurance ; and national consensus standard ASME NQA-1, Quality Assurance Requirements for Nuclear Facility Applications .
+ Technical knowledge of the application of engineering, procurement, and construction practices sufficient to comprehend specified Quality Assurance requirements for these disciplines, including application of the graded approach in an NQA-1 environment, Commercial Grade Dedication, and Software QA.
+ Experience participating in and supporting quality assessments, surveillances, audits, and causal analysis.
+ Demonstrated ability to effectively communicate with all levels of personnel across multiple organizations to solve complex problems.
+ Proven ability to plan, prioritize, and schedule work to ensure completion in accordance with requirements, deadlines, and budget.
Desired Skills
- Possess effective communication skills. Listens carefully and speaks professionally and clearly in all situations. Is able to create, read, and interpret complex written information.
- Capable of developing strong interpersonal networks and trust within the organization, setting expectations and requirements, and achieving accountability of supervised personnel. Leads consensus by involving all stakeholders, facilitating their understanding of differences, agreeing on requirements and constraints, and developing the best solution.
- Capable of identifying and resolving problems in a timely manner, gathering and reviewing information appropriately. Uses own judgment and acts independently, seeks input from other team members as appropriate for complex and sensitive situations.
- Adaptable to changes in the work environment, manages competing demands and is able to deal with frequent interruptions, changes, delays, or unexpected events.
- Strong technical writing skills. Good communication, computer, presentation, and interpersonal skills. Exceptional organizational skills and ability to manage complex quality oversight of projects with multiple work phases, locations, and distributed resources.
- Demonstrated understanding and implementation of quality assurance regulations, standards and guidelines of ASME/NQA-1. NQA-1 Lead Auditor Qualification is a plus.
Education and Experience
- Education: A minimum of a bachelor's degree or equivalent experience.
- Experience: A minimum of 2 years related experience,
- Quality Assurance experience should include knowledge of the elements of NQA-1
- In-depth understanding of engineering, procurement, and construction concepts, principles, theories, and their attendant quality requirements.
- Proven track record of managing staff from multiple disciplines and coordinating quality oversight of all project activities.
Additional Details
- Position will be located in Scoville, ID
- Domestic travel may be required
Essential Functions: Intermittent sitting, walking, standing, bending, squatting, climbing, kneeling, twisting, and lifting. Lifting requirements are limited to 40 lbs. in the form of supplies, drawings, etc. Hand manipulation is required for simple grasping, pushing, and pulling, and fine manipulation. Right and/or left hands utilized. Occasional need to reach and/or work above the shoulder, as well as below the shoulder. Must be alert to equipment in the field, there may be occasional travel, may include work near construction job site equipment when in the field, occasional need to work near hazardous equipment and machinery, occasional need to walk on uneven ground, exposure to dust, gas or fumes, exposure to noise, extremes in temperature or humidity, and potential work at heights. We help prepare people for new opportunities and challenges. With positions at every level, openings in multiple disciplines, and expertise in a range of markets and offices around the globe, we create an environment where you can learn, grow, and thrive. From our competitive benefits program to our Health and Safety initiative of Beyond Zero workplace injuries, we believe that you'll find a flourishing career here.The successful candidate to be present on-site for work. The SFHP Facility site is located in Scoville, Idaho (approximately 51 miles from Idaho Falls, Idaho).
Quality Assurance Specialist
Posted today
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Job Description
Join our team as a Quality Assurance Specialist where you will play a crucial role in ensuring the highest quality standards for our products and processes. You will conduct inspections using hand measurement tools and Optical CMM, maintain SOPs and quality records, and drive quality improvements across the board.
Responsibilities
+ Conduct product and process inspections using hand measurement tools such as micrometers and calipers, and Optical CMM.
+ Maintain and control SOPs, quality records, and work instructions.
+ Identify and lead initiatives to improve product and process quality.
+ Educate employees on quality processes and best practices.
+ Track and report quality KPIs to stakeholders.
+ Collaborate with production, engineering, and R&D teams.
+ Utilize customer feedback to identify issues and drive improvements.
+ Identify, document, and address quality deviations through nonconformance management.
+ Perform internal audits and inspections of products and processes.
Essential Skills
+ Proficiency in quality assurance and quality tools such as Root Cause Analysis (5 Whys, Fishbone), and FMEA.
+ Strong data analysis and visualization skills using Excel, Tableau, and Power BI.
+ 1-2 years of experience in manufacturing and quality.
+ Experience with QMS, ERP (SAP, Oracle), and document management systems.
+ Understanding of regulatory standards such as ISO, FDA, and GMP.
+ Excellent written and verbal communication skills.
Additional Skills & Qualifications
+ Good documentation skills.
+ Basic knowledge of micrometers and calipers.
+ Ability to work in both office and manufacturing settings.
Work Environment
The role involves primarily working on a computer documenting data, with some work on the manufacturing floor. There is a strong emphasis on computer-based tasks, providing a balance between office and floor environments. The project is extensive, offering significant growth opportunities.
Pay and Benefits
The pay range for this position is $23.00 - $26.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Sturgeon Bay,WI.
Application Deadline
This position is anticipated to close on Aug 27, 2025.
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 (% ) for other accommodation options.
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Quality Assurance Specialist
Posted today
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Job Description
The Quality Assurance Specialist will spend the majority of their time on the production floor, assisting the operations team with verifications, conducting general walkthroughs, performing onsite reviews, and executing mini-audits to ensure compliance. They will also be responsible for identifying solutions to problems, such as initiating deviations. Document review, including executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary, is also part of this role. Approximately 80-85% of the time will be spent on the floor, with the remainder in the office. Gowning requirements vary from safety shoes to full protective gear, depending on the area.
Responsibilities
+ Assist the operations team with verifications and general walkthroughs.
+ Perform onsite reviews and mini-audits to ensure compliance.
+ Identify solutions to problems, such as initiating deviations.
+ Review documents, including executed batch records, cleaning records, and logbooks.
+ Issue batch records as needed.
Essential Skills
+ Quality assurance expertise.
+ Experience with FDA regulations.
+ Batch record and CAPA (Corrective and Preventive Action) management.
+ Audit and document control skills.
+ Pharmaceutical industry knowledge.
Additional Skills & Qualifications
+ Bachelor's degree in any science discipline preferred.
+ 2+ years of experience in a regulated industry (GMP/FDA/ISO) for specialists.
+ 5+ years of experience in a regulated industry for Sr. positions.
+ 7+ years of experience in a regulated industry for lead positions.
+ Experience supervising direct reports or leading teams is a plus.
Work Environment
The role involves working primarily on the production floor, with some time spent in an office environment. Employees work on nights (4pm to 4am) with a rotating schedule of 3 days on, 2 days off, 2 days on, and 3 days off. Training is conducted on the first shift, Monday to Friday, from 8 am to 4:30 pm for 6-8 weeks. Employees must adhere to varying gowning requirements, from safety shoes to full protective gear, depending on the area.
Pay and Benefits
The pay range for this position is $62000.00 - $9000.00/yr.
Medical, dental, 401K, vision
Workplace Type
This is a fully onsite position in Madison,WI.
Application Deadline
This position is anticipated to close on Aug 27, 2025.
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 (% ) for other accommodation options.