3 Quality Control jobs in Manati
Quality Control Specialist - Remote
00918 San Juan, Puerto Rico
Sharecare
Posted 3 days ago
Job Viewed
Job Description
**Job Description:**
Sharecare is the leading digital health company that helps people - no matter where they are in their health journey - unify and manage all their health in one place. Our comprehensive and data-driven virtual health platform is designed to help people, providers, employers, health plans, government organizations, and communities optimize individual and population-wide well-being by driving positive behavior change. Driven by our philosophy that we are all together better, at Sharecare, we are committed to supporting each individual through the lens of their personal health and making high-quality care more accessible and affordable for everyone. To learn more, visit .
Job Summary:
The Quality Control Specialist is responsible for reviewing electronic medical records and conducting quality control on each record to ensure we are within HIPAA (Heath Insurance Portability and Accountability) guidelines. This position requires a high attention to detail, while producing quality work at all times.
Essential Job Functions:
+ Ability to check electronic records for HIPAA compliance, compliance with request and authorization limits
+ Ability to review a document and determine if we have the legal right to release medical records based on HIPAA rules and regulations
+ Communicate questions/issues to Lead/Supervisor
+ Work as a mentor to new employees
+ Adhere to state and Federal Laws for Release of Information (ROI)
Specific Skills/ Attributes:
+ High attention to detail
+ Strong time management skills
+ Ability to work in a fast-paced, production-oriented environment
+ Ability to work well with others within a team environment
+ High level of reliability and productivity
+ Must be computer literate; able to use MS Outlook and other Windows-based programs
+ Excellent communication skills
Qualifications:
+ Minimum of 6 months previous experience in a medical record setting
+ Required to pass an industry related course and exam within six months of hire
HIPAA/Compliance:
+ Maintain privacy of all patient, employee, and volunteer information and access such information only on a need to know basis for business purposes.
+ Comply with all regulations regarding corporate integrity and security obligations
+ Report unethical, fraudulent, or unlawful behavior or activity
+ Maintain current and yearly HIPAA certification.
Information Governance Accountabilities:
+ A high-level understanding of the organization's information governance program and role-specific accountabilities
+ A thorough understanding of role requirements, including policies, procedures and processes, to include how individual work impacts the organization and its strategic and financial goals; and how tasks and projects affect the integrity of the organization's data and information
+ Commitment to discuss questions and recommendations about processes and any observed variations in performing tasks in order to ensure a standardized approach to work and services provided
+ Participation in education as required for corporate compliance and role-specific functions and tasks
Physical Requirements:
+ Ability to sit or stand for long periods of time
+ Physical ability to lift and carry 25 lbs. of materials
+ Manual dexterity and strength sufficient enough to enter information via computer keyboard for long periods of time, to write notes and information needed, and to pick up and hold paperwork, supplies and other items.
+ Eyesight sufficient to effectively read documents and to accurately view information on a computer monitor
+ Speaking and hearing ability sufficient to effectively communicate.
+ Eye/hand coordination, hearing and visual acuity necessary for day-to-day tasks
Sharecare and its subsidiaries are Equal Opportunity Employers and E-Verify users. Qualified applicants will receive consideration for employment without regard to race, color, sex, national origin, sexual orientation, gender identity, religion, age, equal pay, disability, genetic information, protected veteran status, or other status protected under applicable law.
Sharecare is an Equal Opportunity Employer and doesn't discriminate on the basis of race, color, sex, national origin, sexual orientation, gender identity, religion, age, disability, genetic information, protected veteran status,or other non-merit factor.
Sharecare is the leading digital health company that helps people - no matter where they are in their health journey - unify and manage all their health in one place. Our comprehensive and data-driven virtual health platform is designed to help people, providers, employers, health plans, government organizations, and communities optimize individual and population-wide well-being by driving positive behavior change. Driven by our philosophy that we are all together better, at Sharecare, we are committed to supporting each individual through the lens of their personal health and making high-quality care more accessible and affordable for everyone. To learn more, visit .
Job Summary:
The Quality Control Specialist is responsible for reviewing electronic medical records and conducting quality control on each record to ensure we are within HIPAA (Heath Insurance Portability and Accountability) guidelines. This position requires a high attention to detail, while producing quality work at all times.
Essential Job Functions:
+ Ability to check electronic records for HIPAA compliance, compliance with request and authorization limits
+ Ability to review a document and determine if we have the legal right to release medical records based on HIPAA rules and regulations
+ Communicate questions/issues to Lead/Supervisor
+ Work as a mentor to new employees
+ Adhere to state and Federal Laws for Release of Information (ROI)
Specific Skills/ Attributes:
+ High attention to detail
+ Strong time management skills
+ Ability to work in a fast-paced, production-oriented environment
+ Ability to work well with others within a team environment
+ High level of reliability and productivity
+ Must be computer literate; able to use MS Outlook and other Windows-based programs
+ Excellent communication skills
Qualifications:
+ Minimum of 6 months previous experience in a medical record setting
+ Required to pass an industry related course and exam within six months of hire
HIPAA/Compliance:
+ Maintain privacy of all patient, employee, and volunteer information and access such information only on a need to know basis for business purposes.
+ Comply with all regulations regarding corporate integrity and security obligations
+ Report unethical, fraudulent, or unlawful behavior or activity
+ Maintain current and yearly HIPAA certification.
Information Governance Accountabilities:
+ A high-level understanding of the organization's information governance program and role-specific accountabilities
+ A thorough understanding of role requirements, including policies, procedures and processes, to include how individual work impacts the organization and its strategic and financial goals; and how tasks and projects affect the integrity of the organization's data and information
+ Commitment to discuss questions and recommendations about processes and any observed variations in performing tasks in order to ensure a standardized approach to work and services provided
+ Participation in education as required for corporate compliance and role-specific functions and tasks
Physical Requirements:
+ Ability to sit or stand for long periods of time
+ Physical ability to lift and carry 25 lbs. of materials
+ Manual dexterity and strength sufficient enough to enter information via computer keyboard for long periods of time, to write notes and information needed, and to pick up and hold paperwork, supplies and other items.
+ Eyesight sufficient to effectively read documents and to accurately view information on a computer monitor
+ Speaking and hearing ability sufficient to effectively communicate.
+ Eye/hand coordination, hearing and visual acuity necessary for day-to-day tasks
Sharecare and its subsidiaries are Equal Opportunity Employers and E-Verify users. Qualified applicants will receive consideration for employment without regard to race, color, sex, national origin, sexual orientation, gender identity, religion, age, equal pay, disability, genetic information, protected veteran status, or other status protected under applicable law.
Sharecare is an Equal Opportunity Employer and doesn't discriminate on the basis of race, color, sex, national origin, sexual orientation, gender identity, religion, age, disability, genetic information, protected veteran status,or other non-merit factor.
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0
Senior Manager, Quality Control Laboratory
00617 Utuado, Puerto Rico
AbbVie
Posted 2 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head.
Responsibilities:
+ Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.
+ Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.
+ Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
+ Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.
+ Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.
+ Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.
+ Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.
+ Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.
+ Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.
+ Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.
Significant Work Activities:
+ Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required
+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
+ Bachelor's degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.
+ Experience managing raw and incoming materials.
+ Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.
+ Supplier Quality Programs knowledge and experience.
+ The selected candidate must be fully bilingual written and verbal, both in English and Spanish.
+ Experience with SmartQC, LIMS (Sample Manager), Empower is desired.
+ Previous experience leading teams.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head.
Responsibilities:
+ Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.
+ Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.
+ Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
+ Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.
+ Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.
+ Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.
+ Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.
+ Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.
+ Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.
+ Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.
Significant Work Activities:
+ Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required
+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
+ Bachelor's degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.
+ Experience managing raw and incoming materials.
+ Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.
+ Supplier Quality Programs knowledge and experience.
+ The selected candidate must be fully bilingual written and verbal, both in English and Spanish.
+ Experience with SmartQC, LIMS (Sample Manager), Empower is desired.
+ Previous experience leading teams.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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1
Branch Quality Control Analyst (Remote- New Mexico)
00918 San Juan, Puerto Rico
UMB Bank
Posted 3 days ago
Job Viewed
Job Description
The **Branch Quality Control Analyst** is responsible for performing independent, quality control reviews of retail branch locations to identify operational and compliance risk within the retail branch. This associate works closely with the Compliance and Oversight Program Manager and reports to the Director of Compliance & Oversight for Consumer Banking. This associate has to be located within the state of New Mexico.
**_How you'll spend your time:_**
+ Ensuring each review includes, at a minimum: an assessment of branch documentation, certification of cash on hand at the branch, observation of associate behavior and interviews with branch associates to assess the associate's understanding of applicable regulatory requirements.
+ Issuing a summary memorandum of each retail branch quality control review performed, including an overall risk rating articulating the level of risk observed in the branch review.
+ Maintaining an ongoing risk rating guide accurately depicting the amount of risk within each retail branch.
+ Assisting in operations related projects, as needed.
+ Cultivate working partnerships with the Consumer Operations teammates and the Consumer Delivery Team.
+ Collaborate with partners and support Consumer Banking to respond to requests from and timely resolve issues identified by regulatory bodies, internal audits or compliance engagements, or self-assessments.
+ Evaluate operational documentation for monthly operational reporting of branch performance.
+ Act as a supportive resource regarding Consumer Banking operations matters.
+ Support Director of Compliance & Oversight in the aggregation and communication of Compliance & Oversight activities including data aggregation, analysis, and reporting.
**_We're excited to talk with you if:_**
+ 5-7 years of branch / bank operations experience.
+ High school diploma or equivalent.
+ Must live within a major metropolitan area of the UMB footprint.
+ Have the ability to work independently with minimal supervision.
+ Have the ability to build relationships and inspire trust across the organization.
+ Have the ability to present and convey information in a way that is easily understandable to associates at varying levels within the organization.
+ Have the proficient writing ability and strong experience with Microsoft Suite software and related banking applications.
+ Ability to travel up to 75% of a scheduled work week.
**Compensation Range:**
$44,790.00 - $86,510.00
_The posted compensation range on this listing represents UMB's standard for this role, but the actual compensation may vary by geographic location, experience level, and other job-related factors. In addition, this range does not encompass the full earning potential for this role. Please see the description of benefits included with this job posting for additional information_
UMB offers competitive and varied benefits to eligible associates, such as Paid Time Off; a 401(k) matching program; annual incentive pay; paid holidays; a comprehensive company sponsored benefit plan including medical, dental, vision, and other insurance coverage; health savings, flexible spending, and dependent care accounts; adoption assistance; an employee assistance program; fitness reimbursement; tuition reimbursement; an associate wellbeing program; an associate emergency fund; and various associate banking benefits. Benefit offerings and eligibility requirements vary.
**Are you ready to be part of something more?**
You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people who care about their work, one another, and their community. Expect more than the status quo. At UMB, you can expect more heart. You'll be valued for exactly who you are and encouraged to support causes you care about. Expect more trust. We want you to do the right thing, no matter what. And, expect more opportunities. UMBers are known for having multiple careers here and having their voices heard.
_UMB and its affiliates are committed to inclusion and diversity and provide employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including gender, pregnancy, sexual orientation, and gender identity), national origin, age, disability, military service, veteran status, genetic information, or any other status protected by applicable federal, state, or local law. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to_ _to let us know the nature of your request._
_If you are a California resident, please visit our_ Privacy Notice for California Job Candidates ( _to understand how we collect and use your personal information when you apply for employment with UMB._
**_Who we are_**
We are more than a company. We are advisors, consultants, problem solvers, friends, community members, experts, and we are here to help you make the best of every moment with a financial foundation that can help you succeed.
Learn more about UMB's vision ( out the road to a career at UMB
**_How you'll spend your time:_**
+ Ensuring each review includes, at a minimum: an assessment of branch documentation, certification of cash on hand at the branch, observation of associate behavior and interviews with branch associates to assess the associate's understanding of applicable regulatory requirements.
+ Issuing a summary memorandum of each retail branch quality control review performed, including an overall risk rating articulating the level of risk observed in the branch review.
+ Maintaining an ongoing risk rating guide accurately depicting the amount of risk within each retail branch.
+ Assisting in operations related projects, as needed.
+ Cultivate working partnerships with the Consumer Operations teammates and the Consumer Delivery Team.
+ Collaborate with partners and support Consumer Banking to respond to requests from and timely resolve issues identified by regulatory bodies, internal audits or compliance engagements, or self-assessments.
+ Evaluate operational documentation for monthly operational reporting of branch performance.
+ Act as a supportive resource regarding Consumer Banking operations matters.
+ Support Director of Compliance & Oversight in the aggregation and communication of Compliance & Oversight activities including data aggregation, analysis, and reporting.
**_We're excited to talk with you if:_**
+ 5-7 years of branch / bank operations experience.
+ High school diploma or equivalent.
+ Must live within a major metropolitan area of the UMB footprint.
+ Have the ability to work independently with minimal supervision.
+ Have the ability to build relationships and inspire trust across the organization.
+ Have the ability to present and convey information in a way that is easily understandable to associates at varying levels within the organization.
+ Have the proficient writing ability and strong experience with Microsoft Suite software and related banking applications.
+ Ability to travel up to 75% of a scheduled work week.
**Compensation Range:**
$44,790.00 - $86,510.00
_The posted compensation range on this listing represents UMB's standard for this role, but the actual compensation may vary by geographic location, experience level, and other job-related factors. In addition, this range does not encompass the full earning potential for this role. Please see the description of benefits included with this job posting for additional information_
UMB offers competitive and varied benefits to eligible associates, such as Paid Time Off; a 401(k) matching program; annual incentive pay; paid holidays; a comprehensive company sponsored benefit plan including medical, dental, vision, and other insurance coverage; health savings, flexible spending, and dependent care accounts; adoption assistance; an employee assistance program; fitness reimbursement; tuition reimbursement; an associate wellbeing program; an associate emergency fund; and various associate banking benefits. Benefit offerings and eligibility requirements vary.
**Are you ready to be part of something more?**
You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people who care about their work, one another, and their community. Expect more than the status quo. At UMB, you can expect more heart. You'll be valued for exactly who you are and encouraged to support causes you care about. Expect more trust. We want you to do the right thing, no matter what. And, expect more opportunities. UMBers are known for having multiple careers here and having their voices heard.
_UMB and its affiliates are committed to inclusion and diversity and provide employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including gender, pregnancy, sexual orientation, and gender identity), national origin, age, disability, military service, veteran status, genetic information, or any other status protected by applicable federal, state, or local law. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to_ _to let us know the nature of your request._
_If you are a California resident, please visit our_ Privacy Notice for California Job Candidates ( _to understand how we collect and use your personal information when you apply for employment with UMB._
**_Who we are_**
We are more than a company. We are advisors, consultants, problem solvers, friends, community members, experts, and we are here to help you make the best of every moment with a financial foundation that can help you succeed.
Learn more about UMB's vision ( out the road to a career at UMB
View Now
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