Data reviewer job description

Our client, one of the largest financial services firms, is seeking an Data Quality Review and Analysis
Jacksonville, FL

Position Type: Contract

Job Responsibilities:


Data Quality Review and Analysis on Self-Identified and External issues in iCAPS/Company Risk & Controls Platform. Ability to work in close liaison and coordination with business stakeholders and sponsors to elicit, analyze, communicate, plan, manage, validate, and prioritize requirements and build strong professional relationship. Act as a Subject Matter Expert for risk categorization of Issues. Ability to understand and translate business problems and capability to perform end to end analysis of Issues. Performs business analysis to respond to business questions and provides end to end governance of delivery. Ability to perform, manage and lead efficiently under tight deadlines and dynamic work environment. Strong analytical and problem-solving skills and willingness to ask questions and challenge existing processes for operational efficiencies. Ability to communicate business requirements to a broad range of technical, non-technical, diverse stakeholders and team members. Exceptional interpersonal and partnership skills and the ability to positively influence outcomes, particularly in difficult matters. Personable and reliable self-starter who requires minimal management oversight for day-to-day work responsibilities. Highly motivated and able to adapt to changing priorities. Ensures project completion, special assignments, and other ad hoc activities as required. Assist manager and manage end of end delivery of program deliverables. Can exercise independence of judgement and autonomy. Summarize and present analysis in concise, though-provoking and action driven manner. Prepare materials and present results of analysis to PBWM and business senior management


Required Skills & Experience:



1-3 years relevant experience. Customer focused with excellent Interpersonal skills and ability to work well in a team environment collaborating across diverse groups. Demonstrated understanding of operational risk and gap identification. SCRA regulatory policies and procedures knowledge. Knowledge/Experience in Issue Management and issue data quality reviews preferred. Extensive relevant experience in operational risk management. Knowledge of risk taxonomy concepts and industry standards. Relevant experience in risk identification, assessment, monitoring, and remediation will be an additional strength. Experience of managing/working on complex projects, with variable stakeholders and within tight deadlines.


Desired Skills:



Ability to multi-task and manage multiple projects simultaneously. Ability to present a compelling case to influence others where appropriate. Excellent verbal and written communication skills Analytical skills and presentation skills. Outstanding attention to detail. Excellent proficiency in Microsoft Office.

This individual will support quality control activities in the field of AAV therapeutic release and stability conducted both internally at Sarepta Andover facility and at contract vendors such as contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs). The work involves reviewing data gathered from routine testing as well as from validations and qualifications. The scope will also include generating certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), and oversight of CTLs. The individual will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner.
Primary Responsibilities Include:
Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, dd PCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta. Monitor, compile, and review analytical and QC data individually and with team members. Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents. Create and maintain clear and concise records and documentation. Support the method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material. Trend data for qualified materials, release products, and stability products. Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites. Act as company liaison with CMOs to coordinate in method development, method transfer, and release and stability testing across various CMO/CRO sites as needed. Author and review test methods, development reports, study protocols, and validation reports. Perform other related duties incidental to the work described.

Desired Education and Skills:
B.S. or M.S. degree in molecular biology, cell biology or virology with at least 2-5 years relevant experience. Working experience in a cGMP environment is preferred. A strong understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays. A familiarity with compendial (USP, ICH, EP) guidance is highly desired. Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary. Experience in developing, validating and deploying molecular biology test methods is useful. Must have effective written and verbal communication skills Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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Contract Length: 6 months

Due to the urgency and specificity of our need, we can only respond to candidates who have the proven specific experience noted below:

Responsibilities:

• The CQ Technical Data Reviewer reviews data from physical and dimensional testing of commodities, wet chemical techniques and instrumental analyses.
• Included in this review are visual evaluations, titrations, pH measurements, AA, HPLC, GC and UV/Vis among other analyses. In addition to data review, this individual could be responsible for preparing solutions, performing analyses, as well as recording and processing data in accordance with DEA, FDA, and ICH guidelines, as needed.
• Functions as a dedicated data reviewer for the Chemical Quality Lab.
• Prioritizes data review and testing with guidance from Data Coordinator or supervisor.
• Assists in monitoring laboratory metrics associated with turnaround goals.
• As needed, prepares solutions required for testing, performs analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.
• Provides support to assure lab safety and compliance -either through safe use of chemicals and/or the recognition of DEA, FDA, OSHA, and ICH compliance issues.

Requirements:

• Bachelor of Science in Life Science (e.g. Chemistry, Biology, Microbiology, etc.)
• Minimum of 5 years of experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.).
• Knowledge of cGMPs and regulations outside of the US.
• Good communication, organization and computer skills are required.
• Knowledge of LIMS, Empower, and Microsoft Office programs is desired.
• Minimum of 1 year data review experience with minimum 5 yrs Lab Experience in pharmaceutical manufacturing environment.
• Minimum of 4-5 years of experience reading and interpreting chromatographic data.
• ICP-MS Experience Preferred