Qa Investigation Reviewer Jobs

Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.

Able to effectively multi-task and execute project management skills.

Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.

Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.

Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.

Proposes solutions for complex issues and works with management to resolve.

Good organization and time management skills.

Proficient computer & typing skills - working knowledge of MS Office: Word, Excel and Outlook

Knowledge of insurance policies and appropriate application of coverage.

Two plus years of related property claim handling experience.

Decision making skills and the ability to work independently.

Analytical and proactive claim handling skills.

Accordance with good documentation practices (GDP), product specifications, process parameters and regulatory requirements.

Communicate effectively with cross functional departments to ensure on time delivery of corrections, QA review and disposition responsibilities.

Review of analytical reports to ensure that products, material, components and intermediates meet company standards and regulatory requirements.

4+ years’ experience within the pharmaceutical, biologic, medical device or regulated industry.

2+ years’ experience in a Quality Assurance/Quality Control or Manufacturing function.

1+ year batch record and analytical data review experience required.

Demonstrate knowledge of and adherence to EH&S safety requirements for site

Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts

Excellent written and verbal communication and interpersonal skills

Demonstrate strong knowledge/understanding of the principles and concepts of aseptic technique and manufacturing operations.

Ph.D. with 0-2 years of experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry .

Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

Investigate claims in order to provide information that is missing or cannot be determined by processors

Contact providers and members to obtain information necessary to process claims

Screen, code, count, and sort batches and logs all work to be distributed to staff

Ensures prompt and efficient distribution of work

Research provider numbers on the claims system to ensure accurate processing

A High School diploma or equivalent

Good computer skills are essential for this job, since data entry of investigation results is a primary part of the job.

Knowledge of regulations and standards affecting IVD?s and Biologics.

Must have good written and oral communications skills.

MUST HAVE BASIC COMPUTER SKILLS TO NAVIGATE INTERNET PROGRAMS, BASIC EXCEL AND FOLLOW STEP BY STEP INSTRUCTIONS.

Experience in the Medical Device / Biotech Industry is preferred.

Knowledge of Electronic Troubleshooting is preferred.

Assist Management team during Pre-Approval and general GMP inspections by the USFDA and external auditors.

At least 2-5 years of testing and data review and cGMP experience

Knowledge of HPLC/GC principles and ability to review data for accuracy and completeness

Experience in quality systems auditing (internal and/or external) preferred

Knowledge of cGMP regulations and validation principles

Well-developed communication and technical writing skills

Able to work with others in a fast-paced, team environment and to interact effectively with all levels of management

Excellent written and verbal communications skills

Interpersonal skills; proven ability to develop skill-set to meet and exceed performance standards

Skills that will help you in the role:

Managing assigned case volume and ensuring adherence to department quantity and quality standards

Identifying service delivery failures and escalating issues or impact to appropriate business owners and leadership

Conduct investigations of potential waste, abuse, and fraud

Document activity on each case and refer issues to the appropriate party

Perform data mining and analysis to detect aberrancies and outliers in claims

Develop new queries and reports to detect potential waste, abuse, and fraud

Provide case updates on progress of investigations and coordinate with Health Plans on recommendations and further actions and/or resolutions

Assist with complex allegations of healthcare fraud