4,260 Validation Specialist jobs in the United States
Validation Specialist
Posted today
Job Viewed
Job Description
Title: Validation Technician
Location: Indianapolis, IN – 46268
Duration: 6 Months
(Mon-Fri 8am - 5pm)
Onsite role Indianapolis
Description:
The holder of this position is charged with supporting the critical aspects of operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.
• Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.
• Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.
• Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Client QM, QD and global regulations.
• Interact/collaborate with Tech/Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.
• Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.
• Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.
• Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.
Academic/Technical Qualifications:
• Bachelor’s Degree in a Science, Engineering or relevant discipline
• 5+ years relevant pharmaceutical and/or validation/qualification experience
Specialist/Technical Qualifications:
• Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment
• Must be (or quickly become) familiar with the relevant areas of science applicable in area(s) of deployment
• Must be (or quickly become) familiar with the general areas of Technical knowledge / understanding
Job Type: Contract
Experience:
• Pharmaceutical: 5 years (Required)
• Validation/Qualification: 5 years (Preferred)
Education:
• Bachelor's (Required)
Validation Specialist

Posted 15 days ago
Job Viewed
Job Description
**This is a Hybrid position based out of our RTP, NC Office.**
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation.
+ Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation.
+ Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required.
+ Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
+ Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
+ Write test cases to validate critical control points, user requirements, and functional designs.
+ Execute test cases as needed.
+ Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
+ Assists in analyzing validation data to ensure acceptance criteria are met.
+ Assists in writing validation summaries.
+ Ensure milestones and timelines are met on assigned projects.
+ Prepares validation reports for distribution.
+ Evaluates adequacy of corrective actions.
+ Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
+ Prepares validation equipment for use at the Donor Center and for evaluation upon return.
+ Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.
+ Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.
+ Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes.
+ Monitors and trends customer complaints and nonconformance related to equipment failures.
**Education & Experience**
+ Bachelor's degree.
+ Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
+ Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
EEO / Minorities/Disabled/Women/Veteran
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
#LI-Hybrid
#biomatusa
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** Quality
CDI Validation Specialist
Posted 3 days ago
Job Viewed
Job Description
POSITION SUMMARY :
The CDI Validation Specialist assists the CDI Manager with oversight, evaluation, and analysis of CDI functions including efficiency, accuracy, continuing education needs, and overall quality. This individual identifies individual education needs of Clinical Documentation Specialists and collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to develop appropriate training materials. The primary goal of ensuring the documentation in the chart identifies all clinical findings, diagnoses and procedures; and are appropriately and clinically supported. The CDI Validations Specialist will work with the CDI Manager to leverage performance, providing feedback and influence to continually improve documentation results thereby impacting key performance indicators.
Position: CDI Validation Specialist
Department: Clinical Documentation
Schedule: Full Time
ESSENTIAL RESPONSIBILITIES / DUTIES:
The CDI Validation Specialist functions primarily as an interdisciplinary auditor and educator focusing primarily on ensuring physician documentation is complete, accurate and representative of the care provided to the system's patients. To that end, the CDI Senior Validator will have access to physicians and clinical staff to participate in and assist in ensuring the ongoing documentation improvement effort is successful. The CDI Senior Validator will report directly to the CDI Manager.
Other functions include the following:
-
Monitors CDI staff accuracy, data quality and integrity.
-
Monitors CDS review process for content, timeliness and accurate diagnosis and procedure assignment in determining a working DRG.
-
Monitors concurrent queries for compliancy, accuracy, clarity, and timeliness.
-
Audits clinical documentation specialists retrospectively to assess for completes of chart review and query compliance including missed query opportunities, accurate coding, and adherence to AHIMA/ACDIS compliant query guidelines/standards
-
Collaborates with CDI manager to identify, coordinate, and implement CDI specialist ongoing education and feedback based on identified opportunities for improvement via auditing.
-
Assists in orientation and training of new clinical documentation specialists
-
Reviews and analyzes denial claims and denial data to provide support in denial prevention strategies via clinical validation query process and education to CDI specialists.
-
Contributes to departmental and organizational quality performance goals, including auditing mortality and readmission cohorts to identify opportunities for improvement. Coordinate and implement CDI specialist education based on identified opportunities.
-
Collaborates with CDI manager to create and update documentation tools, processes, procedures, and work flows on an ongoing and as needed basis.
-
Reviews charts concurrently with no MCC/CCs, low SOI/ROMs and LOS not supported by working DRG.
-
Identifies and educates CDI with missed query opportunities.
-
Assists CDI manager with final DRG validation when there is a discrepancy between CDS and coder.
-
Collaborates with the CDI Manager and identifies opportunities for performance improvement activities on processes.
-
Collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to strategize appropriate training methodology for individual issues.
-
Provides timely appropriate feedback to CDI Manager on any performance improvement plans for CDI staff.
-
Collaborates with other CDCI department managers to identify areas for improvement and solutions for process improvement.
-
Assures documentation is compliant with federal and state regulations, coding guidelines and hospital policies.
-
Remains up-to-date in clinical and coding/documentation-related materials, including CDS best practices as defined by ACDIS as well as ICD-10-CM/PCS, AHA Coding Clinic guidelines for coding and reporting and MS-DRG/APR-DRG classification systems.
-
Monitors regulatory and reimbursement changes.
-
Serves as resource for CDI informational needs and updates CDI on coding changes, medical science and CDI practice standards.
-
Provides guidance, support and expertise to the CDI specialists
-
Track trends in documentation concerns and implementing solutions for improvement.
-
Uses leadership and critical thinking skills to identify opportunities for team processes and engagement
-
Recommend solutions for improvement when deficiencies are identified.
-
Provides CDI specialists, coders, and coding validation specialists with clinical feedback to assist in accurately capture diagnoses and/or opportunities for querying physicians post discharge for additional information.
-
Evaluates the success of concurrent documentation improvement on an ongoing basis.
-
Advances professional growth and development through participation in educational programs and workshops and maintaining knowledge of industry standards and practices.
-
Assists manager, when requested, in the development of APR/DRG/query response physician reports. Maintains complete confidentiality of patient information in addition to hospital and individual physician practice pattern data.
-
Assumes operational oversight of CDI department in the absence of the CDI manager.
-
Adheres to all BMC's RESPECT behavioral standards.
-
Other duties as assigned.
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).
JOB REQUIREMENTS
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree (or equivalent) in nursing, health information management or related field and at least five years (5) years experience in clinical documentation, or equivalent combination of education and experience, required.
PREFERRED EDUCATION AND EXPERIENCE:
Master's degree
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
Licensed RN
CERTIFICATES, LICENSES, REGISTRATIONS PREFERRED:
CCDS, CDIP
KNOWLEDGE, SKILLS & ABILITIES (KSAs):
-
Demonstrate advanced knowledge of clinical documentation integrity practices, policies, workflows, and analysis.
-
Critical thinking, analytical and problem solving skills
-
Highly organized with strong project/task management skills
-
Knowledge of federal, state and payer specific regulations, policies and guidelines pertaining to coding (inpatient or outpatient), documentation requirements and billing
-
Experience with 3M Encoder/Grouper, SMART software preferred
-
Knowledge of care delivery documentation systems and related medical record documents.
-
Knowledge of age-specific needs and the elements of disease processes and related procedures.
-
Strong broad-based clinical knowledge and understanding of pathology/physiology of disease processes.
-
Excellent written and verbal communication skills.
-
Excellent critical thinking skills.
-
Demonstrated employee and medical staff relationships in the past and has the ability to maintain those going forward.
-
Working knowledge of inpatient admission criteria.
-
Ability to work independently in a time-oriented environment.
-
Computer literacy and familiarity with the operation of basic office equipment.
-
Assertive personality traits to facilitate ongoing physician communication.
-
Ability to be adapt to changes in the workload, to work independently and effectively prioritize work assignments
-
Working knowledge of Medicare reimbursement system and coding structures preferred, but not required.
-
Familiarity with physician practices, health information, case management or related healthcare discipline
-
Familiarity with all government health care reimbursement systems
-
Have experience working collaboratively with diverse groups in a health care environment
-
Demonstrated success in interacting effectively with physicians
-
Excellent speaking, writing and teaching skills
-
Proficient with standard Microsoft programs (i.e. MS Word, Excel, PowerPoint, Outlook) and web browsers.
-
Ability to analyze large amounts of data to identify trends.
-
Ability to provide direction and development to employees by coaching, identifying training needs, assigning progressively challenging projects, and assisting in career development planning.
Equal Opportunity Employer/Disabled/Veterans
According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or "apps" job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.
Data Validation Specialist
Posted 3 days ago
Job Viewed
Job Description
We are currently seeking a full-time Data Verification Specialist to join our Parking Management team! The Data Verification Specialist is responsible for accurately reviewing, validating, and/or completing data entry of required data fields from predefined handwritten citation forms, hearing requests, evidence, other correspondence and documents, pictures, and videos.
Essential Job Functions:
- Accesses and utilizes customized data verification applications to review a visual representation of a scanned document, picture, and/or video on a workstation monitor and quickly review, validate, enter, or correct the information presented before moving on to the next record.
- Possesses fast, accurate keyboarding skills (general typing and data entry) with the ability to complete 10,000 keystrokes per hour. (A keystroke is an individual letter, number, space, or another character).
- Works under time constraints at a continuous steady pace while paying close attention to detail in order to complete data validation and verification within the appropriate Service Level Requirement time periods.
- Follows business processes and procedures to accurately apply guidelines to determine the validity of various citation events, such as determining when a vehicle is running through a red light or committing a speeding infraction when a child is present in the surrounding environment.
- Ability and willingness to complete special assignments or assist in other areas of the project based upon availability and fluctuation in volumes.
- High School Diploma or equivalent, required ;
- Associate's Degree, preferred;
- Commits to minimal absenteeism and maintenance of an excellent attendance record.
- Possesses basic computer skills, including working knowledge of Windows operating system; starting and stopping of various software applications; opening, closing, and saving of electronic files; and utilizing mouse and keyboard for basic functions.
- Excellent interpersonal communication skills; written and oral.
- Possesses a positive attitude and pays close attention to detail.
- General knowledge of office equipment; printers, copy machines, and fax machines.
- Must be production oriented and comfortable working to meet daily processing goals and targets.
- Ability to sit for long periods of time.
- Ability to complete manual and repetitive tasks.
Note: Applicants must be currently authorized to work in the United States on a full-time basis. This position is not eligible for visa sponsorship, and we are unable to sponsor or take over sponsorship of employment visas at this time.
William Everett is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
Engineering Validation Specialist

Posted 1 day ago
Job Viewed
Job Description
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives/Purpose of the Job:**
This position will perform and/or support the qualification/validation of the following validation elements: manufacturing/ packaging equipment, facilities, utilities, computerized systems, temperature-controlled areas/equipment, Media Fills, and sterilization processes associated with the manufacture of pharmaceutical products to assure compliance with cGMPs, Regulatory, and BLPs guidelines.
Job assignments are to be completed with supervision of a Validation or Project Manager.
Assume the responsibility for the cGMPs and Environmental Health and Safety procedure awareness, and compliance within the respective area.
**Key Activities/Responsibilities:**
+ Develops sound scientific rationale/strategy for Qualification/ Validation of new or modified cGMP equipment, facilities, computerized systems, temperature-controlled areas / equipment, utilities and/or sterilization processes, as applicable.
+ Write and execute protocols to qualify/validate any of the above validation elements following the latest cGMP regulations.
+ Assess and perform timely process/equipment/systems re-qualifications and/or revalidations to confirm and provide evidence that such process/equipment/systems remain in a validated state.
+ Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.
+ Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.
+ Participate in continuous improvement projects related to validation programs and procedures.
+ Review change control documents, work orders, document change requests for assessing impact on validated systems.
+ Obtain and maintain access to the Aseptic Core Area
+ Open to a flexible and fluid sterile, non-sterile, controlled working Environment.
+ Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
+ Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
+ Ensure that validation activities meet the requirements of FDA (21 CFR 820 and 21 CFR 11), EU Annex 11, ISO13485:2016 and FDA Data Integrity requirements and any other.
+ Perform all other tasks, projects, and duties as assigned.
**Qualifications/Training:**
+ Bachelor's Degree in Engineering or any Science Disciplined degree.
+ Minimum 1-3 years of Engineering or Validation experience.
+ Experience in any of following types of validation is desired: utilities, facilities, manufacturing equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, and ethylene oxide; Media Fills, temperature-controlled area/equipment and Computerized systems.
+ Organizational, analytical, computer, writing and communication skills.
+ Excellent logical/mechanical aptitude desired.
+ Knowledge of basic cGMP regulations and latest validation guidelines.
+ Able to handle multiple priorities in a fast-paced environment.
+ Able to work extended/odd hours around manufacturing schedule required.
+ Must be able to read, write, and speak English and possess math skills.
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.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement.
Our Benefit Programs:Employee Benefits: Bausch + Lomb
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#LI-KF
IVR Validation Specialist

Posted 15 days ago
Job Viewed
Job Description
Our top Pharmaceutical client is seeking a Documentation and Validation specialist to join their External Call Center team within their Patient Experience Org, The are currently insourcing their call center capabilities for supporting end-to-end patient journey's and are in need for a resource with IVR and Contact Center knowledge to spearhead documentation and validation of processes. The ideal resource will have experience with Salesforce Service Cloud, Visio, PPT, and other process documentation tools to document workflows and validation.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: and Requirements
5+ years' in contact center support
Extensive documentation and validaiton skills
knowledge of CRM and Patient Health Information data requirements
Validation Specialist (Indianapolis)
Posted today
Job Viewed
Job Description
Title: Validation Technician
Location: Indianapolis, IN 46268
Duration: 6 Months
(Mon-Fri 8am - 5pm)
Onsite role Indianapolis
Description:
The holder of this position is charged with supporting the critical aspects of operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.
Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.
Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.
Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Client QM, QD and global regulations.
Interact/collaborate with Tech/Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.
Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.
Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.
Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.
Academic/Technical Qualifications:
Bachelors Degree in a Science, Engineering or relevant discipline
5+ years relevant pharmaceutical and/or validation/qualification experience
Specialist/Technical Qualifications:
Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment
Must be (or quickly become) familiar with the relevant areas of science applicable in area(s) of deployment
Must be (or quickly become) familiar with the general areas of Technical knowledge / understanding
Job Type: Contract
Experience:
Pharmaceutical: 5 years (Required)
Validation/Qualification: 5 years (Preferred)
Education:
Bachelor's (Required)
Be The First To Know
About the latest Validation specialist Jobs in United States !