Claims Quality Control Analyst Jobs

Experience: 1-3+ years of relevant work experience or equivalent combination of education and training

Skills: Proficient in Microsoft Office products, including advanced data functions in Excel.

Excellent analytical skills; Ability to collect and analyze data and present findings.

Strong organizational skills and attention to detail.

Strong verbal, written and interpersonal skills.

Charting for scorecard and governance packages.

Functional proficiency with an electronic Quality Management System

Perform studies to assist in qualification of QC test methods.

Experience in cell culture including aseptic technique

Experience with Good Documentation Practices

Perform QC release testing on cell and media products.

Write/review/revise SOPs related to quality control testing including test methods, equipment use, maintenance and calibration.

Three or more years of industry lab experience with HPLC, GC, GC/MS, LC/MS, ICP-MS, NMR required

GMP and ISO experience a plus

Hands-on experience with Biovia LIMS/LES system strongly preferred, Cheminformatics experience a plus

Must be able to multi-task in a fast-paced environment and possess strong verbal and written communication skills

Responsible for troubleshooting basic issues with supervisory oversight

Responsible for basic maintenance of equipment

In depth knowledge of anti-money laundering typologies, regulations, and guidance (BSA, KYC, etc.)

Superior oral and written communication/feedback skills

Proactive in partnering and communicating with Compliance/LOB partners.

Bachelors or advanced degree in business administration, criminal justice, intelligence studies or other related field of study

Participate in validation and technical transfer of analytical methods commensurate with experience

BA or B.S. degree in a science discipline required, or comparable experience

Prior experience related to method development/validation

Knowledge of pharmaceutical cGMP (US and EU) is preferred

Must have excellent verbal, written, interpersonal, and organizational and communication skills

Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples

Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

Minimum 1 year of related experience preferred

Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment would be ideal

Has technical problem-solving ability and analytical skills.

What Takeda can offer you:

Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.

Review data, identify discrepancies, and escalate issues to management

Participate in method qualification/validation activities as necessary

Analyze, document, and report experimental data in accordance with Resilience requirements

Perform method transfer and qualification activities

2-5 years relevant life science experience

Experience in mammalian cell culture

Knowledge of calibration and operation of HPLC system with empower software.

Hands on experience in handling equipment like HPLC, Dionex, GC, UV Visible Spectrophotometer.

Write and review Standard Operating Procedures for assays and qualifications associated with timelines.

Knowledge on Analytical Method Validation.

BS, Life Science with minimum 2+ years of experience in HPLC

Good communication and writing skills.

Strong knowledge and understanding of Managed Healthcare.

Ability to demonstrate initiative and discipline in time management and assignment completion

Bachelor’s degree in Finance or Accounting or equivalent experience.

Include minimum education, technical training, and/or experience preferred to perform the job.

Excellent communication skills, written and verbal.

Must display excellent interpersonal skills

Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.

Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.

Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.

Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.

Review QC analytical assays including method qualification and validation assays.

Typically requires a bachelor's degree and 2+ years of related experience in a GMP QC role.

Important Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and science understanding.

What Takeda can offer you:

Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation, and data trending.

Work in multiple departmental and cross-functional teams and projects; inspection and regulatory support.

Basic: 10-Key, Alphanumeric Data Entry, Contact Management, Database

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Intermediate: Accounting, Spreadsheet, Word Processing/Typing

The noise level in the work environment is usually moderate.

FDA regulated industry (food, pharmaceutical or medical device) experience is required.

Minimum of 3 years relevant experience required.

Strong work ethic and organizational skills.

MAIN JOB RESPONSIBILITIES / COMPETENCIES

Pay range is $65k to $85k - Final compensation will depend on experience.

High School diploma or GED.

Participate in monthly compliance meetings, as deemed necessary by management

Special projects as assigned by management

Come join our team and work remote from home!

High School Diploma or equivalent work experience

3+ years of Auditing Loan Servicing experience required

Working knowledge of Loan Servicing

Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA , FDA/CVM, HS&E, etc.).

Exhibit detail oriented documentation skills to ensure Right-First-Time testing.

Support other laboratory activities as directed by laboratory manager.

In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.

Preferred 1-2 years’ experience working in a pharmaceutical GMP environment.

Experience with HPLC and / or GC and working in a GMP laboratory environment is required.

Assesses process improvements needs utilizing a structuredrequirements process (gathering, analyzing, documenting, andmanaging changes) to assist in identifying priorities and advises onoptions.

Assists in the development of user manuals and knowledgedatabases and assist in user training.

Design and develop end-to-end automated tests in and otherapplications to validate system functionality.

Create and maintain Automation framework in support of a variety ofmobile (Appium) and web (Selenium) applications.

Support the execution, debugging and fixes of automated test suites,including providing strategies to minimize test rework and falsepositives.

Support development of automated component tests to validateindividual component behavior.

Coordinate customer repairs Manage Document Change Control (DCR)

Manage product rentals and loaners

3-5 years’ experience in Quality Role.

Demonstrated Critical Thinking skills with focus on improved performance outcomes and positive business impact.

Working knowledge of FDA Quality System Regulations, ISO-13485.

Write and update Standard procedures in compliance to QMS

Time management and organizational skills being able to handle multiple priorities in a fast-paced environment

Field questions from various levels of management pertaining to testing results

Review and understand client specifications and benefit design builds through RxPlan and PharmScreens software platforms

Build/Run standard and custom batch claim files for clients in all lines of business and benefit design complexities

Perform benefit compare analysis between PharmScreens and RxPlan

Serve as point of contact for other departments troubleshooting plan/benefit configuration related questions through claims testing

Work collaboratively with internal Field Operations team to establish (remotely from central office)

High School Diploma / GED (or higher) or equivalent work experience.

Medical Assistant, CMA, CNA or MEDIC/prior Combat Medic experience a plus.

Experienced in Excel, Google Sheets

Demonstrated STRONG organizational skills and attention to detail

Demonstrated excellent written and verbal skills