Quality Systems Specialist II Job at Tucker Parker Smith Group (Hercules)

Quality Systems Specialist II

The Quality Systems Specialist II position is responsible for the support of a c...

Location

United States , Burnsville

Salary:

75000.00 - 110000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a related technical field
3-5 years of experience in quality assurance or other quality systems roles in the medical device industry
Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies
Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements
Advanced computer skills, including statistical/data analysis and report writing skills
Strong verbal and written communication skills
Excellent attention to detail
Multitasks prioritize and meet deadlines promptly

Job Responsibility

Develops and maintains quality system procedures to ensure compliance with regulations and industry standards
Participates in internal and external quality audits to ensure compliance with regulations and standards
Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records
Investigate and resolve quality issues, including conducting root cause analysis and implementing corrective and preventive actions
Leads meetings and communications for CAPA updates, information, and concerns
Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions
Provides backup support for engineering change orders and other document change requests
Develops and maintains electronic quality management system processes
Provides cross-functional training and support as needed
Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...

Location

United States , Durham, NC

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA’s
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Specialist II, Supplier Quality

The purpose of this position is to provide quality assurance support for the Sup...

Location

United States , Verona

Salary:

70000.00 - 85000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on Supplier Quality
Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents

Job Responsibility

Support supplier qualification, requalification, and ongoing monitoring activities for raw material suppliers, CMOs, contract laboratories, packaging vendors, and service providers
Assist with supplier risk assessments and ensure documentation is current and compliant
Collaborate with stakeholders and suppliers, as needed, on quality events and non-conformances and issue supplier corrective action requests, as outlined in the applicable quality agreements
Assist with maintenance of approved supplier lists and supplier quality records
Review and assess supplier change notifications for quality and regulatory impact
Ensure timely and accurate documentation within the Quality Management System (QMS)
Track and trend supplier performance metrics (e.g., deviations, on-time CAPA closure, audit findings)
Identify recurring issues and support continuous improvement initiatives
Assist with preparation, update, review, and routing of Arrowhead procedural documents
Assist with other QA duties as needed

What we offer

competitive salaries and an excellent benefit package

Fulltime

Clinical Documentation Integrity (CDI) Specialist II

The Clinical Documentation Integrity Specialist is responsible for utilizing ind...

Location

United States , Shaker Heights

Salary:

74090.00 - 115898.00 USD / Year

University Hospitals

Expiration Date

Until further notice

Requirements

Associate’s Degree in health related field or Other Accredited Program: Diploma in RN
2+ years in CDI Specialist role
3+ years clinical and/or ICD-10 coding experience, preferably in a large academic medical center
Experience using clinical computer systems
Must have thorough, up-to-date clinical skills (i.e. current working knowledge of pathology, pharmacology, surgical procedures, etc.)
Excellent written and verbal communication skills including presentations
Ability to function independently and as a team player in a fast-paced environment
Detail-oriented, and relationship building skills
Demonstrates and has extensive knowledge of disease pathophysiology
Demonstrated ability to use PCs, Microsoft Office suite, and general office equipment (i.e., printers, copy machine, FAX machine, etc.)

Job Responsibility

Ensures documentation is accurate and complete by performing timely medical record review and determination of code assignment by applying clinical and/or coding expertise to identify opportunities for improved or clarified documentation that accurately reflects the patient complexity and resource utilization
Direct and timely follow-up with clinical providers to ensure requested clarification is provided
Responsible and accountable for expanding CDI and coding knowledge (keeping up to date on latest research, technology, treatment modalities, etc.)
Utilizes critical thinking/problem solving processes
Appropriately utilizes and interprets professional association resource materials and regulatory agencies guidelines to enhance own skill sets: Coding Clinics, AHIMA, CMS guidelines
Identifies query opportunities for record integrity
Is proficient in query writing so that the question is easily understood by the physician
Query writing is AHIMA compliant per practice briefs
Escalates non-response to query by physicians immediately according to query escalation policy
Collaborates with the coding team

Fulltime

Payroll Specialist II

Carex is partnering with a biotech industry partner to hire a Payroll Specialist...

Location

United States , Madison

Salary:

35.00 - 40.00 USD / Hour

Carex Consulting Group

Expiration Date

Until further notice

Requirements

Experience supporting payroll processing in a multi-state environment
Working knowledge of ADP payroll systems and Workday integrations
Understanding of payroll tax laws, deductions, HSA/FSA programs, and payroll compliance requirements
Strong attention to detail and organizational skills
Ability to manage confidential information with discretion
Strong verbal and written communication skills
Ability to work collaboratively across Payroll, HR, and Accounting teams
Comfortable working in a fast-paced and evolving environment
Ability to prioritize tasks and manage multiple responsibilities effectively
Proficiency with Microsoft Office and payroll-related reporting

Job Responsibility

Assist in the accurate and timely processing of U.S. payrolls
Cross-train with the Lead Payroll Specialist to provide back-up support for payroll processes
Process new hire integrations from Workday and maintain employee pay-related records in ADP
Review daily integration files from Workday for accuracy and communicate potential issues to the Workday team
Update payroll records including tax withholding changes, HSA contributions, and direct deposit information
Partner with Human Resources regarding leaves of absence and related payroll deductions
Assist in resolving payroll discrepancies and employee payroll inquiries
Import employee timecards and support timely manager approvals for hourly payroll processing
Review and import time off files from Workday into ADP
Assist with the distribution of employee pay statements

What we offer

Carex benefits

Fulltime

Clinical Specialist, Quality Management I

Who We Are: Because health is personal. That's why Personify Health created the ...

Location

United States

Salary:

60600.00 - 91000.00 USD / Year

Personify Health

Expiration Date

Until further notice

Requirements

Active, unrestricted Registered Nurse (RN) license required
Basic computer literacy
The ability to work on multiple screens, and proficient typing skills
Proficiency in software applications including, but not limited to, Microsoft Word, Microsoft Excel, and Outlook
Ability to speak clearly and convey complex or technical information in a manner that others can understand, as well as ability to understand and interpret complex information from others
Ability to work independently and utilize written resources to problem solve
After training with our training department and 1.5 months ramp (3 months total), must have and be able to work in: Teams on and off camera, SharePoint, Drives as needed, VPN, UM Web or Health Notes, El Dorado, Quick Links, GIAS, ADP, Confluence, Phone system with headset, Smartsheet
Knowledge of medical claims and ICD-10, CPT, HCPCS coding
Excellent verbal and written communication skills for upward and downward conversations
Level I: In-depth knowledge of applicable regulations and accreditation standards (HIPAA, CMS requirements as applicable, NCQA, URAC)

Job Responsibility

Ensure compliance with state, federal, and accreditation requirements (e.g., HIPAA, CMS, NCQA, URAC, ERISA, as applicable)
Conduct internal and external audits of UM/CM/CDM processes and documentation
prepare audit files, findings, and corrective action recommendations
Identify quality and compliance risks and collaborate with cross-functional partners on mitigation and resolution
Review and support SOPs and workflows to ensure regulatory alignment and operational clarity
Support external audit readiness activities, including NCQA and URAC evidence preparation and maintenance
Develop, maintain, and deliver role-based training curriculum aligned to compliance standards, quality goals, and operational workflows
Conduct onboarding and orientation to prepare staff for assigned UM/CM/CDM functions
Deliver training using multiple modalities (virtual, self-paced, and one-on-one coaching) tailored to adult learners
Ensure training covers applicable processes such as case initiation and closure, documentation standards, high-dollar case monitoring, stop-loss notification, administrative support, customer service, and productivity expectations

What we offer

Competitive base salary and benefits effective day one
Comprehensive medical and dental through our own health solutions (yes, we use what we build)
Unlimited PTO—rest and recharge time is non-negotiable
Mental health support, retirement planning, and financial protection
Professional development with clear career progression and learning budgets
Mission-driven culture where diverse perspectives drive real impact on people's health

Fulltime

Claims Specialist II

Claims Specialist II – Coordination of Benefits (COB) Do you enjoy solving compl...

Location

United States

Salary:

Not provided

Tier4 Group

Expiration Date

Until further notice

Requirements

High School Diploma or equivalent
Minimum of two (2) years of medical claims processing experience
Strong analytical and investigative skills with the ability to resolve complex claims issues
Excellent written and verbal communication skills
Ability to prioritize and manage multiple tasks in a fast-paced environment
Proficiency with claims processing systems and Microsoft Office applications

Job Responsibility

Reviewing and processing medical claims with accuracy and attention to detail
Researching and resolving claim edits, denials, and payment discrepancies
Determining primary and secondary insurance coverage when members have multiple health plans
Applying Coordination of Benefits (COB) rules, including subscriber status, effective dates, plan types, and Medicare coordination guidelines
Updating claims and coverage records to ensure accurate claim adjudication
Investigating previously processed claims and making necessary benefit adjustments
Identifying and recovering overpayments through refunds, reprocessing, and recovery efforts
Communicating with members, providers, healthcare organizations, and insurance carriers to verify coverage and resolve claim issues
Reviewing quality audits and implementing corrections to maintain compliance and processing accuracy
Supporting special projects, process improvements, system updates, and departmental initiatives as needed

Document Management Specialist II

Under limited supervision, the Document Management Specialist I will assist the ...

Location

United States , Camden

Salary:

Not provided

MUSC Health

Expiration Date

Until further notice

Requirements

High School Diploma or equivalent
2 years of experience

Job Responsibility

Prepares records for scanning
ensures all pages are manually designated for proper chart placement
Reviews scanned documents for readability, quality, and document type assignment
assigns document type to images as indicated
acts as a resource for the document imaging system

Fulltime

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Quality Systems Specialist II

Job Description

Job Responsibility

Requirements

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