Role Description The Biologics Drug Substance Senior Quality Assurance Specialist is responsible for performing key Quality tasks in respect of Company Biologics products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Drug Substance Lead, External Manufacturing QA. - Monitoring and supporting the quality performance of contract manufacturing organisations and material suppliers to all applicable GXP standards. - Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations. - CMO Batch file and product testing record review and approval. Associated lot Disposition activity. - Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations. - Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues. - Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required. - Highlighting any risks associated with maintaining supply of commercial drug products to all markets. - Conducting vendor audits and vendor site visits as required. - Assisting in internal audits and regulatory agency inspections. - Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions. - Assisting with the generation of Jazz APQR (Annual Product Quality Review). - Maintaining product related Quality Technical Agreements (QTAs). - Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate. - Reviewing and approving moderate complexity deviations and associated corrective actions. - Supporting the generation of new, as well as improvement of, existing department SOPs. - Supporting delivery of projects. - Working with management to resolve project issues and resource constraints within the team. - Liaising with the internal and external stakeholders to resolve and clarify any point of issue. - Reviewing and approving less complex validation documents. - Partnering with other departments/groups to problem-solve and address moderately complex issues. - Collaborating in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation. - Representing QA in cross-functional project teams for moderately difficult projects. - Participating in and facilitating regulatory inspection readiness. - Coordinating and collaborating with other teams to meet organizational goals and work requirements. - Receiving assignments in the form of objectives and determining how to use resources to meet schedules and goals. - Following processes and operational policies in selecting methods and techniques for obtaining solutions; solving moderately complex problems and can identify viable and often innovative options. - Using analytical skills and judgment to recommend the "best" solution. - Demonstrating success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations. - Maintaining quality from cell banking through to production and post-release events (e.g., stability, product complaints). Qualifications - Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/Biotechnology Industry. - Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of Biologics manufacturing. - Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site. - Experience with contract manufacturing is desirable. - Significant experience (>5 years) of commercial and/or late state clinical phase GMP manufacturing of biologics. - Highly organised, with exceptional time management and prioritization. - Excellent verbal and written communication skills. - Experience in Drug Product Manufacture in addition to Drug Substance is an advantage. - QP eligibility or progress toward QP certification is highly desirable. Requirements - Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline. Benefits - Medical, dental and vision insurance. - Retirement savings plan. - Flexible paid vacation.

Role Description This is an entry-level position that supports the CPPA CORS team by assisting in the review and production of partner site materials about professional behavior, with regular guidance. We are looking for someone who: - thrives in a fast-paced environment with daily deadlines - successfully manages multiple parallel tasks and easily pivots throughout the day - communicates clearly and in a timely manner - has a keen eye for detail - has good reading comprehension - is experienced in using Microsoft Excel and Adobe Acrobat Qualifications - High School Diploma or GED - 2 years of relevant work experience Requirements - Performs quality review and edits of documents. - Assists in analyzing document content and designing intervention and training materials. - Identifies areas for improvement in production process. - Identifies trends/issues in preliminary data and report trends/issues. - Assists in the implementation of interventions. - The responsibilities listed are a general overview of the position and additional duties may be assigned. Benefits - Comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

• Audit fraud operations cases. • Audit dispute cases. • Maintain QA methodology. • Surface themes to leadership. • Drive corrective action. • Calibrate with stakeholders. • Escalate systemic issues.

Role Description Will be a 6-9 month set contract need to support automation within the business office. Contract needs may extend longer. 100% remote role. This role will assist with balancing and posting payments, researching requests, re-allocating funds, and missing check follow ups. Daily Duties: - Responsible for the processing electronic remittance advice according to daily assignment. - Maintain spreadsheets that document activity for each daily deposit with accuracy and attention to detail. Must be able to have strong Excel skills and be comfortable with sorting, filtering, etc. - Responsible for reconciliation of 835 file and deposit amount. - Complete Provider Level Benefits segments (provider adjustments) following the established processes. - Monitor file exchanges to ensure appropriate data is posted. - Process Medicare RAC recoupments & interest to facilitate timely appeal process. - Process remittance advice, check, and/or cash on a timely basis. - Responsible for providing and updating with accurate information in the control log of remittance advice, and/or cash account. - Make all adjustments and/or corrections from pre-edits, errors or unprocessed items. - Process and scan mail daily and balance to bank deposit. Qualifications - High School graduate or equivalent. - 1-2 years of hospital/clinic insurance payment cash posting experience. - Experience with EOB, remittance, working with accounts, and balancing. - 10 key Data entry experience - test at 50 WPM. - Strong Microsoft Excel experience - sorting, filtering. - Work from home space required. Requirements - PREFER 1+ year of medical office experience. - EPIC experience. Benefits - Medical, dental & vision. - Critical Illness, Accident, and Hospital. - 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available. - Life Insurance (Voluntary Life & AD&D for the employee and dependents). - Short and long-term disability. - Health Spending Account (HSA). - Transportation benefits. - Employee Assistance Program. - Time Off/Leave (PTO, Vacation or Sick Leave). Company Description We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.