Principal Specialist, Quality Assurance - Finance Operations
Quality Assurance Specialist job 50 miles from Kokomo
**_What the Risk and Controls team within Global Financial Shared Services contributes to Cardinal Health_** The Risk and Controls team within Global Financial Shared Services is responsible for performing operational, quality, and SOX controls related to pricing processes. The team works closely with Pricing Operations teams within Shared Services, Internal and External Audit, and other business partners. The team is responsible for evaluating new pricing strategies and other improvement activities to assess the appropriateness of existing controls.
**_Responsibilities_**
+ Applies knowledge of auditing, accounting, pricing, and internal control concepts to evaluate financial and operational business activities.
+ Demonstrates knowledge of process flows, process documentation, and internal control identification.
+ Leverages project management skills to define audit testing plans, execute control testing and document testing results.
+ Demonstrates strong interpersonal skills to interact with others in a constructive manner that builds trust.
+ Clearly and accurately documents business processes and related audit findings.
+ Works closely with Pricing Operations teams within Shared Services, Internal and External Audit, and other business partners.
+ Responsible for evaluating new pricing strategies and other improvement activities to assess the appropriateness of existing controls.
**_Qualifications_**
+ 3+ years of experience preferred
+ Bachelor's degree in related field preferred, or equivalent work experience
**_What is expected of you and others at this level_**
+ Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
+ May contribute to the development of policies and procedures
+ Works on complex projects of large scope
+ Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
+ Completes work; independently receives general guidance on new projects
+ Work reviewed for purpose of meeting objectives
+ May act as a mentor to less experienced colleagues
**Anticipated salary range:** $79,700 - $113,800
**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:** 8/27/2025 *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._
_To read and review this privacy notice click_ here (***************************************************************************************************************************
Quality Assurance Auditor - As9100 & As9110
Quality Assurance Specialist job 50 miles from Kokomo
←Back to all jobs at COMLUX AMERICA LLC QUALITY ASSURANCE AUDITOR - AS9100 & AS9110
About us:
Comlux Completions is a leader in luxury private aviation, offering unparalleled opportunity to work on cutting edge projects in aircraft design, maintenance, and operations. At Comlux Completions, you'll join a team of highly skilled experts dedicated to quality, precision, and innovation. We provide a supportive environment where your expertise is valued with opportunities for hands-on experience, professional growth, and career advancement. With competitive benefits, state-of-the-art facility, and a commitment to excellence. Comlux Completion is the perfect place to build a rewarding career while working on world class aircrafts that set the standard for luxury and performance.
Why us:
Hands-on Impact: Be part of projects that shape the world around us.
Cutting edge Tech: Work with state-of-the-art tools and equipment to sharpen your skills.
Flexibility: We value work-life balance, offering schedules that fit your lifestyle.
Team Vibes: Join a supportive crew that values collaboration and celebrates achievements.
What we're looking for:
Problem-solvers who thrive on hands-on work.
Passionate Individuals eager to learn and grow in their craft.
Tech-savvy thinkers who embrace innovation.
Team players with a strong work ethic and attention to detail.
QUALITY ASSURANCE AUDITOR - AS9100 &AS9110
POSITION SUMMARY:
This position supports the Quality Management System (QMS) to include overall compliance with FAA regulations and industry best practices. AS9100 &AS9110
EXAMPLES OF ESSENTIAL JOB FUNCTIONS:
Assists with further development of the QA manual and internal operating procedures, processes and work instructions.
Supports QA management in the development and reporting of key QMS metrics.
Maintains and revises as necessary, QMS documentation.
Ensures proper distribution and accessibility of QMS documentation throughout the company.
Performs internal audits of the QMS to include but not limited to: initiation, follow-up, tracking and closure of Corrective Action Requests (CARs).
Performs internal audits of build records to include but not limited to: task cards, work orders, and other work documentation as required.
Assists QA management with the initiation, follow-up, tracking and closure of Supplier Non-Conformance Reports (SNRs) and Supplier Corrective Action Requests (SCARs).
Audit and document process for , Measurement & Test Equipment (M&TE) calibration system to include but not limited to a calibration recall ensuring all calibrations are performed on a timely basis, and that all M&TE used for RTS is maintained under the calibration recall system.
Provides support to the Receiving Inspectors in the timely resolution of conflicts to prevent (where possible) delays in meeting scheduled production input dates.
Assists in the development and maintenance of AS9100 QMS certification.
Contributes to the training of QMS procedures, processes and work instructions.
All other duties as assigned.
MINIMUM QUALIFICATIONS, EDUCATION, EXPERIENCE, LICENSES, ETC:
HS diploma or GED
Must be proficient in Aviation Quality Assurance best practices to include but not limited to: a thorough knowledge of the 14 CFR Parts 21 and 25, as well as, additional supporting FAA Regulations, Orders, Notices, Advisory Circulars (ACs) and industry guidance related to quality, manufacturing, maintenance and certification.
Previous experience within a Certified Repair Station environment would be considered acceptable.
Must be skilled in the ability to communicate technical issues in an assertive and tactful manner while effectively motivating people of various departments and management levels.
AS9100 or AS9110 lead auditor or auditor preferred. Corrective action training is also preferred.
REQUIRED SKILLS AND ABILITIES:
Skilled in the ability to read, interpret and apply knowledge related to use of type design to include but not limited to: dwgs, specs, schematics, wiring diagrams, etc.
Fosters collaborative working relationships which benefit the overall business activity of Comlux.
Proficient with PC and MS Office tools including MS Outlook, MS Word, MS Excel, MS Project, MS Power Point, MS Access. Power Bi would be a plus.
Must be proficient with FAA RGL, possess the ability to identify, locate and research the necessary regulatory requirements and guidance information.
AS9100 and AS9110 knowledge of the standard desired
WORK ENVIRONMENT:
The work environment described here is representative of those required by an employee to perform the essential functions of this job with or without reasonable accommodations.
The office building where this position works is a typical office environment with minimal exposure to excessive noise or adverse environmental issues in the immediate vicinity of the workstation. The employee in this position will experience occasional outdoor exposure to heat, cold, and environmental elements when called upon to locate personnel working inside or outside of a Hanga
ORGANIZATIONAL STRUCTURE:
Reports to: Head of Quality
Manages: None
Career Path: Quality Manager, Assistant Quality Manager
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive description of all work requirements and responsibilities. The job description does not constitute an employment contract and is subject to change as the needs of the employer and the requirements of the job change. Additionally, the minimum level of education notated as a requirement could be supplemented by commensurate experience and/or certification(s) or license(s) as determined by the hiring manager.
Please visit our careers page to see more job opportunities.
Quality Assurance Specialist
Quality Assurance Specialist job 32 miles from Kokomo
Job Description
Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.
Responsibilities:
Creation, implementation and support of a comprehensive QMS (Quality Management System).
Participate in the qualification of key suppliers, including executing internal and external audits and assessments.
Creation and implementation of processes which support manufacturing of active drug substance, such as issuance of batch records and test records, raw material release, batch record review, and finished drug product release.
Creation and management of site training and development programs, including GMP and GDP training.
Support of critical manufacturing investigations, including out of specification results and deviations in the manufacturing process.
Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Commission, Food and Drug Administration, European Union, etc.).
Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.
Requirements
Bachelor's degree in the life sciences or other technical field is required.
5+ years working in a quality control or quality assurance position supporting GMP manufacturing is required.
Experience working in PET drug or radiopharmaceutical manufacturing under 21 CFR 210, 211 and/or 212 current Good Manufacturing Practices (cGMPs) is strongly preferred.
Strong understanding of GMP and radiation safety principles is preferred.
Detail-oriented mindset with excellent organizational and record-keeping skills.
Effective communication and teamwork abilities, with a focus on collaborative problem solving.
Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
Flexibility to work in shifts or outside of normal business hours to handle time-sensitive processes.
Strong commitment to safety, ethical conduct and compliance with regulations.
Benefits
We offer a competitive salary, a comprehensive package of benefits, and advancement opportunity.
As an equal opportunity employer, we are committed to a diverse workforce.
Customer Service Quality Assurance Specialist III - Quality Assurance Analyst - Journeyman
Quality Assurance Specialist job 50 miles from Kokomo
ASM Research provides services in support of the Military OneSource Program for military members and their families, similar to a commercial Employee Assistance Program (EAP). This program provides a broad array of information, resources, referrals, and counseling to about 4.7 million persons or "participants," which includes military service members, their families, and eligible civilians at locations worldwide. Services are provided through a 24/7 contact center accessible via internet website, toll free telephone, secure real-time text/video chat, email, or postal mail and include non-medical counseling; financial counseling; tax assistance; spouse education and career information; adoption information; child care; Exceptional Family Member Programs (EFMPs); deployment support; disability information; elder care; educational services for adults, children, and youth; relocation services; pet care; health and wellness coaching; housing assistance; legal service referrals; single service member services; lodging; military benefits; relationship support; skill building services for parenting; spouse relocation and transition; peer-topeer support; and support for everyday issues (e.g., locating a plumber or automobile mechanic).
Quality Assurance Analysts provide QA support to monitor performance for all Military OneSource operations to meet minimum standards in the SLAs and Performance Metrics. In this role they will monitor customer interactions and review/analyze customer feedback to evaluate overall customer experience. Assigns root cause and identifies systemic quality problems. Uses data from call observations to create quality improvement action plans and drive projects working with team and third-party vendors. Accurately compares measurements between team, vendors and client partners. Reports findings from complaints and call monitoring to the client, internal, and vendor teams. Makes recommendations on quality initiatives.
**Job Responsibilities**
+ Conducts audits and reviews using scoring protocols for calls and/or case records using a pre-determined set of criteria, documenting results in a detailed report.
+ Supports data entry and analysis following URAC minimum standards and defined SOPs as specified in the Quality Management Plan.
+ Maintains and provides all records and reports pertaining to QA documentation.
+ QA Analysts adhere to and promote auditing standards, participate in team meetings, training requirements and calibration sessions.
+ Supports analysis of Duty to Warn, Adverse Incidents, and Mandated Reporting in compliance with defined processes and reporting standards
+ Monitors customer interactions for timeliness of answer, active listening, request/issue identification, correct call hold, professionalism, compliance requirements, request/issue resolution, and appropriate closing.
+ Analyzes survey results for improving communication process and providing feedback to the communication owners.
+ Utilizes quality monitoring program to compile and track performance at individual, functional, and program levels.
+ Provides feedback to agents and managers based on observed strengths and improvement opportunities.
+ Analyzes readership, comprehension and application of communicated actions.
+ Serves as a resource and escalation point for all lines of business so that reviews of calls are accurate for technical content and employees are provided with the correct policies, procedures, and/or reference materials.
+ Identifies trends in service and provides that data to the training team to enhance current training.
+ Documents customer/call communications processes and makes recommendations.
+ Implements operational process improvement initiatives on a regular basis, as well as through long-term projects.
+ Provides call quality metrics data to generate and maintain volume forecasts to support management with scheduling and staffing needs.
+ Leads brainstorming sessions to improve call system, communications processes, customer satisfaction, agent processes and agent effectiveness.
+ Completes activities related to deploying communications including but not limited to creating checkpoints based on important points, creating surveys for reader feedback and continuous improvement, and providing recommendations for communications process improvement.
+ Coordinates with client to create content for agent communications.
+ Develops and distributes new agent communications, researching content and obtaining appropriate feedback and reviews as needed.
+ Creates and implements training plans to orient new hires and ensure a smooth transition from learning environment to daily production environment.
+ Identifies agent communication needs and makes recommendations to Call Center management.
**Minimum Qualifications**
+ U.S. citizen and fluent English speaker
+ Possess strong written and verbal communication skills
+ Must submit to and successfully pass a DoD-initiated Tier 2 - Public Trust Background Investigation
+ Bachelor's degree and 5 years of contact center quality assurance experience (additional 4 years of work experience may be considered in lieu of Bachelor's degree)
+ Solid working knowledge of standard computer software (Microsoft Office business suite to include Outlook, Word, Excel, PowerPoint, and Project)
**Other Job Specific Skills**
+ Demonstrated ability to contribute to quality assurance program creation or execution.
+ Experience with call center call monitoring/recording software.
+ Exceptional customer service and problem-solving skills.
+ Ability to explain and present ideas clearly and concisely to diverse audiences, using appropriate language.
+ Excellent analytical skills and strong decision-making abilities.
+ Proven ability to achieve and maintain departmental quality standards.
+ Strong Internet software and Windows operating systems and software skills.
+ Demonstrated ability to train and develop new and existing support agents.
+ Excellent interpersonal, facilitation, and relationship management skills.
+ Demonstrated ability to effectively communicate and interact with interdepartmental staff and across organizational lines.
+ Critical thinker with the ability to solve complex problems; able to apply quality improvement techniques.
+ Great coordination skills across multiple departments of the Customer system.
**Compensation Ranges**
Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees.
**EEO Requirements**
It is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.
All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment.
Physical Requirements
The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions.
**Disclaimer**
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
$25.00
EEO Requirements
It is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.
All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.
Quality Assurance Associate
Quality Assurance Specialist job 50 miles from Kokomo
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
Quality assurance associate will have responsibility for reviewing incoming complaints for thoroughness and appropriateness in accordance with policies and procedures.
Review incoming CFs (complaints) for thoroughness of required information, appropriate complaint type selection, timely submission, and appropriate wording for a regulated environment.
Accept or reject incoming CFs (complaints), based on above criteria.
Communicate with CF (complaint) submitters regarding missing information, inaccurate complaint type selection, untimely submission, or inappropriate wording for a regulated environment.
Monitor draft complaints for timely submission.
Submit returned material authorization (RMA) requests to vendor for credit for defective product reported through complaints.
Follow-up with vendor regarding requested RMAs.
Track number of accepted / rejected complaints per day, reasons for rejections, and other pertinent data.
Participate in visual management meeting for complaint handling team.
Complete assigned training in a timely manner.
Cross-train with Manager and peers for any other assignments as applicable.
Qualifications
1-2 years of experience.
Detail oriented, proactive, attention to accuracy, excellent customer service both internally and externally, good documentation skills
Preferred background:
Regulated industry complaint handling experience preferred.
Required Education:
Bachelor's degree, with degree in science or engineering preferred, but not required
Technical/Software tools used: Outlook, Master Control, Excel files, Global CAPA
Top 5 characteristics to be successful in this role:
Detail-oriented, accurate, focused, good documentation skills, business professional
How is performance measured
Timeliness of disposition of incoming complaints; quality of accepted complaints.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (650)-399-0891
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
's
FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Quality Assurance Coordinator - Human Services
Quality Assurance Specialist job 50 miles from Kokomo
Who We Are:
At Dungarvin, we are more than a provider of support services—we’re a mission-driven team rooted in respect, response and choice. Since 1976, we’ve been dedicated to meeting people where they are, working alongside them to provide person centered supports that allow people to live independently as possible. You’ll work directly with people in need of assistance, and/or living with intellectual or developmental disabilities, or other complex medical needs.
With services in 15 states, our team is united by a shared commitment to making a real difference—one person, one voice, one choice at a time. We encourage you to embrace this opportunity to impact someone’s life.
Why This Role:
Personal fulfillment, meaningful career, and the chance to make a difference.
Build meaningful bonds with persons served and their families.
Further develop your leadership experience in the social service field
Varied day-to-day experiences; no two days are the same.
Schedule: Full-time with potential travel throughout the state, mainly Indianapolis, Evansville and Flora.
Pay: $24/hr
Perks/Benefits:
Medical, Vision and Dental Insurance
Supplemental Insurance
Flex Spending and HSA Accounts
Pet Insurance
Life Insurance
401 K plan with 3% employer match at one year of services
PAID TIME OFF (PTO) accrual -
PTO Donation
Growth and Development Opportunities
Employee Referral Program
Scheduled pay increases
Employee Assistance Program
Mileage reimbursement
T-Mobile, Verizon, Dell, and other National Brand Discounts
TapCheck- access to 50% of your pay before payday.
PAID training and orientation.
Job Description
What You Get To Do:
The Quality Assurance Coordinator (QA) is responsible to ensure all programs are in compliance with state regulations and meet Dungarvin standards of quality. The Quality Assurance Coordinator (QA) must be aggressive in finding problems that are or could be a licensing issue. This position works collaboratively with the State Director, Area Directors, Area Managers and other program employees to identify problems, develops plans for correction, and assure that plans are fully implemented. The Quality Assurance Coordinator (QA), will closely monitor the completion of corrective actions to ensure timely completion by program management.
Assess sites for quality assurance concerns as scheduled or upon request.
Conduct ongoing monitoring of sites and follow-up with sites.
Track, review and follow-up on abuse, neglect, and exploitation investigations.
Analyze data from electronic and paper-based systems to inform the management team of quality issues related to service delivery.
Provide in-the-moment training to staff when issues are observed.
Provide support to the management team in responding to Requests for Proposals.
Work closely with recruitment, training and retention leaders to inform the effectiveness of their efforts.
Work with the management team to identify and train QA reviewers where needed.
Work with the management team to develop, communicate, implement and provide feedback regarding prioritized QA goals.
Provide leadership with policies, systems, and initiatives.
Assist in quality assessment, intervention and enhancement of services and supports.
Ensure the programs meet applicable licensure and certification requirements.
Participate in Safety Committee.
Represent the state on related national task forces dedicated to quality assurance.
Work cooperatively with internal and external contacts to ensure services are provided in a timely manner, on a basis of quality according to organizational standards, contractual requirements and regulatory guidelines.
Monitor and audit assigned employee timecards in accordance with payroll deadlines. Authorize overtime and mileage expenses for employees within assigned budgets. Approve timecards while assuring accuracy of pay and benefit category.
Implementation of all organizational policies and procedures.
Act as a role model for the organization’s values, mission, and philosophy.
Represent the organization in a positive, professional, and responsible manner to staff, other professionals, and the community.
Who We Are:
At Dungarvin, we're all about making a positive impact in people's lives. We help individuals with different abilities, like intellectual disabilities, developmental disabilities, physical disabilities, autism, and mental health conditions, in a variety of programs with a focus on providing a person-centered approach. We're all about personal care and support, encouraging our clients to chase their dreams, while our team provides the help, they need to make important choices and get the care they deserve.
Qualifications
What Makes You A Great Fit:
Bachelor's degree in a relevant field, such as healthcare, social work, or psychology
Minimum of 3 years of experience working in the Human Services field
Preferred- at least two years of experience in quality assurance
Strong analytical skills, with the ability to build, review, and interpret complex data
Excellent communication and interpersonal skills
Knowledge of regulatory requirements related to IDD Supports, such as HIPAA, Licensing Requirements, and Person-Centered Service Provision
A successful background clearance is required as part of the onboarding/employment process
Additional Information
At Dungarvin, diversity and inclusion are a part of what makes our organization strong. Together, we can continue to work towards an inclusive culture that supports our employees and persons served. Dungarvin is an affirmative action and equal opportunity employer.
All your information will be kept confidential according to EEO guidelines.
6/23
#LI-BD1
#DINJ
Quality Assurance Coordinator
Quality Assurance Specialist job 50 miles from Kokomo
Job Description
Our Quality, Risk and Compliance teams focus on maintaining compliance and auditing to mitigate risk for our operations. This keeps the company in compliance with State, Federal and overall company requirements, but most importantly to keep our clients safe and help them live their best life. If your passion is ensuring service quality and fostering compliance, read below and apply today!
Responsibilities
Conduct case file and record reviews for compliance and identifies opportunities for improvement or corrective actions and to ensure contractual performance expectations are met
Submit weekly Quality Assurance reports in a timely manner to Project Director
Present consistent feedback to management regarding areas that need improvement
Ensure 100% of clients participate in the client satisfaction survey
Ensure all clients receive a return call within 24 hours of calling and leaving a message
Review quality assurance standards, study existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs
Creates, implements and monitors standard operating procedures
Other duties as assigned
Qualifications
Associates degree in Human Services, education, psychology, sociology or related field required, Bachelors degree preferred
Minimum two plus years related experience
Demonstrate knowledge of quality assurance procedures and federal, state and local coalition laws and mandates
Demonstrate knowledge of computers and knowledge of data management processes
Demonstrate knowledge of eligibility determination processes and filing procedures
QA Document Management Associate
Quality Assurance Specialist job 36 miles from Kokomo
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Role Description
Responsible for implementing and maintaining the Procedures and Document Management process. Includes Good Manufacturing Practice (GMP) library, document inventory, ensuring true copy accuracy, and overseeing document control within our electronic document system. This role also involves developing and delivering training content and providing leadership within the QA team.
Key Responsibilities:
Leadership: Provide guidance and support to the QA Procedures team, fostering a culture of compliance and continuous improvement. This position includes some supervisory responsibilities.
Document Control: Manage document control processes within the electronic document system, ensuring timely updates and compliance with SOPs. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
Document Inventory Management: Oversees the inventory of all QA documents, ensuring accurate tracking and availability. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
GMP Library Maintenance: Implement and ensure the GMP library is up-to-date and accessible, including the organization and archiving of documents.
True Copy Verification: Ensure all documents are true copies, maintaining integrity and compliance with regulatory standards.
SOP Content Creation: Develop and update SOPs related to GMP Library processes, ensuring clarity, compliance, and alignment with regulatory requirements.
Training Content Development and Delivery: Create and deliver training materials to staff, ensuring understanding and adherence to QA processes and regulations.
Basic Qualifications:
Bachelor's degree in a related field (e.g., Life Sciences, Quality Assurance, Regulatory Affairs).
3+ years of experience in a QA compliance role, preferably within a GMP-regulated environment.
Additional Preferences:
Strong knowledge of GMP regulations and document control processes.
Experience with electronic document management systems.
Excellent organizational and communication skills.
Proven ability to develop and deliver effective training programs.
Leadership experience and the ability to work collaboratively within a team.
Strong organizational and time management skills.
Excellent communication and interpersonal skills.
Proficiency in document management systems and software.
Attention to detail and ability to work independently
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Quality Assurance Coordinator - Human Services
Quality Assurance Specialist job 50 miles from Kokomo
Who We Are: At Dungarvin, we are more than a provider of support services-we're a mission-driven team rooted in respect, response and choice. Since 1976, we've been dedicated to meeting people where they are, working alongside them to provide person centered supports that allow people to live independently as possible. You'll work directly with people in need of assistance, and/or living with intellectual or developmental disabilities, or other complex medical needs.
With services in 15 states, our team is united by a shared commitment to making a real difference-one person, one voice, one choice at a time. We encourage you to embrace this opportunity to impact someone's life.
Why This Role:
Personal fulfillment, meaningful career, and the chance to make a difference.
Build meaningful bonds with persons served and their families.
Further develop your leadership experience in the social service field
Varied day-to-day experiences; no two days are the same.
Schedule:
Full-time with potential travel throughout the state, mainly Indianapolis, Evansville and Flora.
Pay: $24/hr
Perks/Benefits:
Medical, Vision and Dental Insurance
Supplemental Insurance
Flex Spending and HSA Accounts
Pet Insurance
Life Insurance
401 K plan with 3% employer match at one year of services
PAID TIME OFF (PTO) accrual -
PTO Donation
Growth and Development Opportunities
Employee Referral Program
Scheduled pay increases
Employee Assistance Program
Mileage reimbursement
T-Mobile, Verizon, Dell, and other National Brand Discounts
TapCheck- access to 50% of your pay before payday.
PAID training and orientation.
Job Description
What You Get To Do:
The
Quality Assurance Coordinator (QA)
is responsible to ensure all programs are in compliance with state regulations and meet Dungarvin standards of quality. The
Quality Assurance Coordinator (QA)
must be aggressive in finding problems that are or could be a licensing issue. This position works collaboratively with the State Director, Area Directors, Area Managers and other program employees to identify problems, develops plans for correction, and assure that plans are fully implemented. The
Quality Assurance Coordinator (QA)
, will closely monitor the completion of corrective actions to ensure timely completion by program management.
Assess sites for quality assurance concerns as scheduled or upon request.
Conduct ongoing monitoring of sites and follow-up with sites.
Track, review and follow-up on abuse, neglect, and exploitation investigations.
Analyze data from electronic and paper-based systems to inform the management team of quality issues related to service delivery.
Provide in-the-moment training to staff when issues are observed.
Provide support to the management team in responding to Requests for Proposals.
Work closely with recruitment, training and retention leaders to inform the effectiveness of their efforts.
Work with the management team to identify and train QA reviewers where needed.
Work with the management team to develop, communicate, implement and provide feedback regarding prioritized QA goals.
Provide leadership with policies, systems, and initiatives.
Assist in quality assessment, intervention and enhancement of services and supports.
Ensure the programs meet applicable licensure and certification requirements.
Participate in Safety Committee.
Represent the state on related national task forces dedicated to quality assurance.
Work cooperatively with internal and external contacts to ensure services are provided in a timely manner, on a basis of quality according to organizational standards, contractual requirements and regulatory guidelines.
Monitor and audit assigned employee timecards in accordance with payroll deadlines. Authorize overtime and mileage expenses for employees within assigned budgets. Approve timecards while assuring accuracy of pay and benefit category.
Implementation of all organizational policies and procedures.
Act as a role model for the organization's values, mission, and philosophy.
Represent the organization in a positive, professional, and responsible manner to staff, other professionals, and the community.
Who We Are:
At Dungarvin, we're all about making a positive impact in people's lives. We help individuals with different abilities, like intellectual disabilities, developmental disabilities, physical disabilities, autism, and mental health conditions, in a variety of programs with a focus on providing a person-centered approach. We're all about personal care and support, encouraging our clients to chase their dreams, while our team provides the help, they need to make important choices and get the care they deserve.
Qualifications
What Makes You A Great Fit:
Bachelor's degree in a relevant field, such as healthcare, social work, or psychology
Minimum of 3 years of experience working in the Human Services field
Preferred- at least two years of experience in quality assurance
Strong analytical skills, with the ability to build, review, and interpret complex data
Excellent communication and interpersonal skills
Knowledge of regulatory requirements related to IDD Supports, such as HIPAA, Licensing Requirements, and Person-Centered Service Provision
A successful background clearance is required as part of the onboarding/employment process
Additional Information
At Dungarvin, diversity and inclusion are a part of what makes our organization strong. Together, we can continue to work towards an inclusive culture that supports our employees and persons served. Dungarvin is an affirmative action and equal opportunity employer.
All your information will be kept confidential according to EEO guidelines.
6/23
#LI-BD1
#DINJ
QA Associate, 3rd Shift
Quality Assurance Specialist job 38 miles from Kokomo
Description Working closely with the QA Operations Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions:
Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc.
Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
Support other QA personnel with batch record reviews, material release, etc.
Prioritize and coordinate his/her time in balancing production timelines with product quality assurances.
Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
Ability to manage multiple projects in a fast-paced environment.
Special Job Requirements:
This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations' needs.
Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.
Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
Understanding of Good Documentation Practices (GDPs) and its criticality.
Excellent written and verbal communication skills.
General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Additional Preferences:
Hands-on experience with aseptic manufacturing.
Experience with Continuous improvement, Six Sigma, and/or Lean principles.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
INCOG BioPharma Services Careers - QA Associate, 3rd Shift
Quality Assurance Specialist job 38 miles from Kokomo
Working closely with the QA Operations Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps.
The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Essential Job Functions:
* Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
* Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc.
* Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
* Support other QA personnel with batch record reviews, material release, etc.
* Prioritize and coordinate his/her time in balancing production timelines with product quality assurances.
* Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
* Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
* Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
* Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
* Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
* Ability to manage multiple projects in a fast-paced environment.
Special Job Requirements:
* This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations' needs.
* Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
* Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.
* Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
* Understanding of Good Documentation Practices (GDPs) and its criticality.
* Excellent written and verbal communication skills.
* General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Additional Preferences:
* Hands-on experience with aseptic manufacturing.
* Experience with Continuous improvement, Six Sigma, and/or Lean principles.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Quality Assurance Associate_Shift_2
Quality Assurance Specialist job 50 miles from Kokomo
Responsible for the meeting of standards for operating and usage of logistic and supply chain, material management, and distribution/transportation policies and practices to meet the business requirements company. They must analyze data for accuracy, report on any improvements implemented, and note any effects of modifications.
JOB RESPONSIBILITIES
Investigate and diagnose quality complaints, track down components, and recommend corrective actions.
Verify logs, databases, and other data to track and flag quality concerns and improvements.
Work with organization members to audit, identify quality problems, and improve operational processes.
Write, maintain, and disseminate quality manuals and other documentation.
Other duties as assigned by management.
QUALIFICATIONS
High School Diploma or equivalent.
Basic mathematical skills.
Ability to read/write and interpret documents.
1-3 years' relevant experience
Preferred:
Bachelor's degree in relevant field preferred
Warehouse experience.
Logistics experience.
PHYSICAL REQUIREMENTS
Requires frequent walking, carrying, reaching, standing, and stooping.
Requires work from heights of up to 20 feet from floor.
Requires work in an environment with frequently changing temperatures.
ADDITIONAL INFO
Ability to work in a fast paced environment.
Good verbal and written communication skills.
Interpersonal skills necessary to establish and maintain effective working relationships with co-workers, other business areas.
Ability to use ladder, hand truck, and dolly.
QA Associate
Quality Assurance Specialist job 50 miles from Kokomo
Job Title: Quality Assurance Associate
GENERAL JOB DESCRIPTION
Were looking for Quality Assurance Associates in our Fulfillment Center to inspect and ensure that all ingredients and all items in boxes meet required quality standards.
MAJOR DUTIES AND RESPONSIBILITIES
Objectives of this Role
Assist Specialist with Gold Standard and table set up
Audit tables on a continuous basis (each table at least once per hour)
Audit bins of finished product continuously (each table at least once per hour, each automated prep at least once every 15 minutes)
Document all audits in Quality Tool Suite
Notify Specialist and Quality Auditor of any issues
Attend monthly refresher trainings with Quality team
Speak with Quality during start up communications
Assist Specialist with calling the line and ensuring accuracy
Audit pack lines on a continuous basis (at least twice per hour)
Audit finished boxes continuously (at least three boxes per hour)
Document all audits in Quality Tool Suite
Notify Specialist and Quality Auditor of any issues
Attend monthly refresher trainings with Quality team
Speak with Quality during start up communications
QUALIFICATIONS FOR THE JOB
Skills and Requirements
Clear and concise communicator, verbal and written.
Ability to work calmly and effectively under pressure.
Ability to work in fast-paced, deadline-oriented environment.
Flexible availability; we work night and weekend shifts.
Must be able to lift up to 49 pounds repetitively with or without reasonable accommodation
Must be able to handle exposure to temperatures that range from freezing to sub-freezing
(coolers, freezers, etc.)
Must be able to stand/walk for up to 10-12 hours with or without reasonable accommodation
Must be willing and able to frequently push, pull, squat, bend, and reach with or without reasonable accommodation
Experience / Education
1-2 years experience in a food production or warehouse environment
Performance Assurance Associate
Quality Assurance Specialist job 50 miles from Kokomo
We have an exciting opportunity for a Performance Assurance Associate to join our team!
The successful candidate will work closely with project managers, developers, and business owners to understand the desired outcome of CIS and CIS interfacing application modifications. They will also prepare test cases to ensure systems are functioning properly after implementation to avoid issues that would present problems for users of the system. Furthermore, they will perform system integrated testing, user acceptance testing, and post implementation validation. Additionally, they will thoroughly document and report system issues and consult with system developers to resolve the issues. They will also provide support, such as troubleshooting issues and answering functional questions, to all users of the application after implementation. Furthermore, they will assist in the development and execution of application and process performance reporting. They will also assist in the development of process, system, and training documentation.
Citizens Energy Group offers a competitive salary and benefits including:
Health, Dental & Vision
Defined Benefit Pension Plan
401(k) Retirement Plan with company match
Short Term Incentive (STIP) Plan
Health Savings Account (HSA) with company contribution
Wellness Program
Adoption and tuition assistance
Employee Credit Union
PTO and Paid Holidays
Flexible Hybrid Work Schedule
If you are looking for a new opportunity, we invite you to apply and talk about the possibilities of starting a rewarding new chapter of your career!
Minimum Hourly Wage: $25.67 (Grade 6)
Responsibilities
Review requirements and design documentation for system modifications and prepare test cases to address all requirements.
Perform system integrated testing, user acceptance testing, and post implementation validation for CIS and CIS interfacing application modifications.
Thoroughly document and report system issues and consult with system developers and business owners to resolve the issues.
As the subject matter expert of CIS and CIS interfacing applications, provide support to business areas by assisting in the creation of training material, troubleshooting production issues, and assisting in the development of new process improvements.
Assist in preparing performance reports to be used by the Performance Assurance Analysts.
Perform other duties as assigned.
Qualifications
High school diploma, preferably with academic study including advanced mathematics and computer technology.
Two or more years of experience interacting with business application software.
Advanced knowledge of Microsoft Excel, Word, PowerPoint, SharePoint, and Access.
Strong written and verbal communication skills.
Self-motivated with the ability to work under pressure and to tight deadlines.
Ability to work on multiple projects simultaneously and manage task priorities.
Excellent problem solving skills.
Preferred Skills/Qualifications
Two or more years of experience working with a Customer Information System (CIS).
Experience in end-user application software testing.
Experience using Structured Query Language (SQL) software.
Obtained or pursuing a Bachelor's Degree from an accredited college or university in Computer Technology, Information Technology, Business or Related Field, or other education deemed appropriate by management.
Job Posting Deadline: Open Until Filled
Citizens is a drug-free, Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, age, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.
Quality Assurance Specialist
Quality Assurance Specialist job 32 miles from Kokomo
Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.
Responsibilities:
Creation, implementation and support of a comprehensive QMS (Quality Management System).
Participate in the qualification of key suppliers, including executing internal and external audits and assessments.
Creation and implementation of processes which support manufacturing of active drug substance, such as issuance of batch records and test records, raw material release, batch record review, and finished drug product release.
Creation and management of site training and development programs, including GMP and GDP training.
Support of critical manufacturing investigations, including out of specification results and deviations in the manufacturing process.
Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Commission, Food and Drug Administration, European Union, etc.).
Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.
Requirements
Bachelor's degree in the life sciences or other technical field is required.
5+ years working in a quality control or quality assurance position supporting GMP manufacturing is required.
Experience working in PET drug or radiopharmaceutical manufacturing under 21 CFR 210, 211 and/or 212 current Good Manufacturing Practices (cGMPs) is strongly preferred.
Strong understanding of GMP and radiation safety principles is preferred.
Detail-oriented mindset with excellent organizational and record-keeping skills.
Effective communication and teamwork abilities, with a focus on collaborative problem solving.
Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
Flexibility to work in shifts or outside of normal business hours to handle time-sensitive processes.
Strong commitment to safety, ethical conduct and compliance with regulations.
Benefits
We offer a competitive salary, a comprehensive package of benefits, and advancement opportunity.
As an equal opportunity employer, we are committed to a diverse workforce.
Quality Assurance, Sr. Coordinator
Quality Assurance Specialist job 50 miles from Kokomo
Cardinal Health Sonexus Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products.
**Together, we can get life-changing therapies to patients who need them-faster.**
**Responsibilities:**
+ Leads the team by evaluating calls and assess application usage based on a standard set of criteria, providing constructive feedback and recognition to ensure high performance and continuous improvement. Accurately score interactions to gauge employee's quality performance based on organizational and departmental policies and requirements.
+ Monitor and evaluate team performance ensuring adherence to company quality standards, and compliance with industry regulations. Tracks and reports any trends from the customer experience that can be improved or celebrated.
+ Analyze and provide weekly & monthly trend analysis to leadership.
+ Provide support to leadership by participating in and hosting internal/external client calibration sessions.
+ Engage in and lead projects to promote quality enhancements and/or broaden services for the team.
+ Shows an understanding of the requirements and is capable of conducting gap assessments based on those requirements. Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures.
+ Collaborates across various functions, interprets requirements, and educates and influences others regarding those requirements. Identifies training needs or potential disciplinary actions which will be reported to leadership.
+ Demonstrates ability to build strong customer relationships and deliver customer-centric solutions.
+ Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement.
+ Develops strategic alliances and cooperates with stakeholders to achieve mutual goals.
+ Demonstrates resourcefulness by adeptly securing and efficiently deploying resources.
+ Analyzes complex and high-quality, sometimes contradictory, information to solve problems effectively.
+ Holds oneself and others accountable for meeting commitments and objectives.
+ Exhibits situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations.
+ Creates and implements diverse communication strategies that clearly address the specific requirements of various target audiences.
+ Demonstrates knowledge of quality systems and methodologies.
+ Demonstrates an understanding of the relevant regulations, standards, and operating procedures.
+ Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
+ Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
+ Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
+ Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
**Qualifications:**
+ Call monitoring/audit experience preferred.
+ Case audit experience preferred.
+ HS Diploma, GED or technical certification in related field or equivalent experience, preferred.
+ Adverse Event reporting experience strongly preferred.
+ Strong customer service/quality background experience.
+ Excellent verbal and written communication skills
+ Strong prioritization and leadership skills.
+ High regard for superior quality of service.
+ Ability to prioritize and manage multiple responsibilities.
+ Experience handling tasks where attention to detail is critical to success.
+ 3+ years' experience in related field, preferred.
**What is expected of you and others at this level:**
+ Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments.
+ In-depth knowledge in technical or specialty area
+ Applies advanced skills to resolve complex problems independently.
+ May modify process to resolve situations.
+ Works independently within established procedures; may receive general guidance on new assignments.
+ May provide general guidance or technical assistance to less experienced team members.
**TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CST, mandatory on camera attendance is required.
This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 8:00am- 5:00pm CST.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable.
+ Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**Anticipated hourly range:** $17.90 per hour - $26.88 per hour
**_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:** 05/25/2025 *if interested in opportunity, please submit application as soon as possible.
The hourly 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._
_To read and review this privacy notice click_ here (***************************************************************************************************************************
Quality Assurance Associate
Quality Assurance Specialist job 50 miles from Kokomo
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
Quality assurance associate will have responsibility for reviewing incoming complaints for thoroughness and appropriateness in accordance with policies and procedures.
Review incoming CFs (complaints) for thoroughness of required information, appropriate complaint type selection, timely submission, and appropriate wording for a regulated environment.
Accept or reject incoming CFs (complaints), based on above criteria.
Communicate with CF (complaint) submitters regarding missing information, inaccurate complaint type selection, untimely submission, or inappropriate wording for a regulated environment.
Monitor draft complaints for timely submission.
Submit returned material authorization (RMA) requests to vendor for credit for defective product reported through complaints.
Follow-up with vendor regarding requested RMAs.
Track number of accepted / rejected complaints per day, reasons for rejections, and other pertinent data.
Participate in visual management meeting for complaint handling team.
Complete assigned training in a timely manner.
Cross-train with Manager and peers for any other assignments as applicable.
Qualifications
1-2 years of experience.
Detail oriented, proactive, attention to accuracy, excellent customer service both internally and externally, good documentation skills
Preferred background:
Regulated industry complaint handling experience preferred.
Required Education:
Bachelor's degree, with degree in science or engineering preferred, but not required
Technical/Software tools used: Outlook, Master Control, Excel files, Global CAPA
Top 5 characteristics to be successful in this role:
Detail-oriented, accurate, focused, good documentation skills, business professional
How is performance measured
Timeliness of disposition of incoming complaints; quality of accepted complaints.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (650)-399-0891
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Quality Assurance Coordinator - Human Services
Quality Assurance Specialist job 50 miles from Kokomo
Who We Are: At Dungarvin, we are more than a provider of support services-we're a mission-driven team rooted in respect, response and choice. Since 1976, we've been dedicated to meeting people where they are, working alongside them to provide person centered supports that allow people to live independently as possible. You'll work directly with people in need of assistance, and/or living with intellectual or developmental disabilities, or other complex medical needs.
With services in 15 states, our team is united by a shared commitment to making a real difference-one person, one voice, one choice at a time. We encourage you to embrace this opportunity to impact someone's life.
Why This Role:
* Personal fulfillment, meaningful career, and the chance to make a difference.
* Build meaningful bonds with persons served and their families.
* Further develop your leadership experience in the social service field
* Varied day-to-day experiences; no two days are the same.
Schedule: Full-time with potential travel throughout the state, mainly Indianapolis, Evansville and Flora.
Pay: $24/hr
Perks/Benefits:
* Medical, Vision and Dental Insurance
* Supplemental Insurance
* Flex Spending and HSA Accounts
* Pet Insurance
* Life Insurance
* 401 K plan with 3% employer match at one year of services
* PAID TIME OFF (PTO) accrual -
* PTO Donation
* Growth and Development Opportunities
* Employee Referral Program
* Scheduled pay increases
* Employee Assistance Program
* Mileage reimbursement
* T-Mobile, Verizon, Dell, and other National Brand Discounts
* TapCheck- access to 50% of your pay before payday.
* PAID training and orientation.
Job Description
What You Get To Do:
The Quality Assurance Coordinator (QA) is responsible to ensure all programs are in compliance with state regulations and meet Dungarvin standards of quality. The Quality Assurance Coordinator (QA) must be aggressive in finding problems that are or could be a licensing issue. This position works collaboratively with the State Director, Area Directors, Area Managers and other program employees to identify problems, develops plans for correction, and assure that plans are fully implemented. The Quality Assurance Coordinator (QA), will closely monitor the completion of corrective actions to ensure timely completion by program management.
* Assess sites for quality assurance concerns as scheduled or upon request.
* Conduct ongoing monitoring of sites and follow-up with sites.
* Track, review and follow-up on abuse, neglect, and exploitation investigations.
* Analyze data from electronic and paper-based systems to inform the management team of quality issues related to service delivery.
* Provide in-the-moment training to staff when issues are observed.
* Provide support to the management team in responding to Requests for Proposals.
* Work closely with recruitment, training and retention leaders to inform the effectiveness of their efforts.
* Work with the management team to identify and train QA reviewers where needed.
* Work with the management team to develop, communicate, implement and provide feedback regarding prioritized QA goals.
* Provide leadership with policies, systems, and initiatives.
* Assist in quality assessment, intervention and enhancement of services and supports.
* Ensure the programs meet applicable licensure and certification requirements.
* Participate in Safety Committee.
* Represent the state on related national task forces dedicated to quality assurance.
* Work cooperatively with internal and external contacts to ensure services are provided in a timely manner, on a basis of quality according to organizational standards, contractual requirements and regulatory guidelines.
* Monitor and audit assigned employee timecards in accordance with payroll deadlines. Authorize overtime and mileage expenses for employees within assigned budgets. Approve timecards while assuring accuracy of pay and benefit category.
* Implementation of all organizational policies and procedures.
* Act as a role model for the organization's values, mission, and philosophy.
* Represent the organization in a positive, professional, and responsible manner to staff, other professionals, and the community.
Who We Are:
At Dungarvin, we're all about making a positive impact in people's lives. We help individuals with different abilities, like intellectual disabilities, developmental disabilities, physical disabilities, autism, and mental health conditions, in a variety of programs with a focus on providing a person-centered approach. We're all about personal care and support, encouraging our clients to chase their dreams, while our team provides the help, they need to make important choices and get the care they deserve.
Qualifications
What Makes You A Great Fit:
* Bachelor's degree in a relevant field, such as healthcare, social work, or psychology
* Minimum of 3 years of experience working in the Human Services field
* Preferred- at least two years of experience in quality assurance
* Strong analytical skills, with the ability to build, review, and interpret complex data
* Excellent communication and interpersonal skills
* Knowledge of regulatory requirements related to IDD Supports, such as HIPAA, Licensing Requirements, and Person-Centered Service Provision
* A successful background clearance is required as part of the onboarding/employment process
Additional Information
At Dungarvin, diversity and inclusion are a part of what makes our organization strong. Together, we can continue to work towards an inclusive culture that supports our employees and persons served. Dungarvin is an affirmative action and equal opportunity employer.
All your information will be kept confidential according to EEO guidelines.
6/23
#LI-BD1
#DINJ
Quality Assurance Associate - Drug Product External Manufacturing
Quality Assurance Specialist job 29 miles from Kokomo
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Overview
Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.
The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.
Key Objectives/Deliverables:
Lead/ provide support to launch new products/ packages/ CMs
Participate on Joint Process Teams
Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.
Levelling, reviewing, and approving of event investigations and changes.
Work with Lilly support groups and SME's to resolve product related issues
Participate in the creation and revision of standard operating procedures
Participate on Six Sigma Projects to help improve productivity
Provide support on site or remotely during inspections
Author and track compliance to the CM Quality Agreements and CM Quality Plans
Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess/monitor performance.
Routinely have face-to-face communications with CMs
Track and monitor Quality metrics for trends at the CM
Support Qualifications/ Validation document creation and reviews
Provide and coordinate designated sections for Annual Reports and Annual Product Reviews
Execute SOP assessments of CMs and track completion of outstanding issues
Support CMs effort to maintain and improve their quality systems
Provide technical leadership and project management oversight to drive improvements to CM quality systems
Build and maintain regular communication with External Manufacturers and awareness of issues/progress including reporting back to DPEM Management. Also responds to request of information and data.
Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight
Network with external partners and resources to share and learn best practices and trends within the industry
Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
Basic Qualifications:
Bachelor´s Degree in Pharmacy, Chemistry, Biological Science or other relevant field
5+ year of parenteral product manufacturing and quality experience
Additional Skills/ Preferences:
Knowledge of Pharmaceutical Manufacturing Operations
Strong written and communication skills, especially attention to detail in written procedures and protocol development.
High learning agility.
Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
Ability to organize, prioritize, multi-task and influence others.
Strong decision making and problem-solving skills.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Proven ability to work independently or as part of a Team to problem solve
Regulatory related experience.
Established technical, quality, and internal networks.
Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
Preferable minimum of 5 years of experience supporting manufacturing
Additional Information:
Shift is days, but off-hours may be necessary to support operations
Travel up to 30%
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Quality Assurance Coordinator
Quality Assurance Specialist job 50 miles from Kokomo
Our Company
ResCare Community Living
Our Quality, Risk and Compliance teams focus on maintaining compliance and auditing to mitigate risk for our operations. This keeps the company in compliance with State, Federal and overall company requirements, but most importantly to keep our clients safe and help them live their best life. If your passion is ensuring service quality and fostering compliance, read below and apply today!
Responsibilities
Conduct case file and record reviews for compliance and identifies opportunities for improvement or corrective actions and to ensure contractual performance expectations are met
Submit weekly Quality Assurance reports in a timely manner to Project Director
Present consistent feedback to management regarding areas that need improvement
Ensure 100% of clients participate in the client satisfaction survey
Ensure all clients receive a return call within 24 hours of calling and leaving a message
Review quality assurance standards, study existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs
Creates, implements and monitors standard operating procedures
Other duties as assigned
Qualifications
Associates degree in Human Services, education, psychology, sociology or related field required, Bachelors degree preferred
Minimum two plus years related experience
Demonstrate knowledge of quality assurance procedures and federal, state and local coalition laws and mandates
Demonstrate knowledge of computers and knowledge of data management processes
Demonstrate knowledge of eligibility determination processes and filing procedures
About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn.
Salary Range USD $21.10 / Hour