Title:  Senior Data Review Specialist

Job Summary

In this role, you will be responsible to independently provide review of analytical data generated for all internal and external customers. This position will focus on the review of data from the Extractables group which includes GC/MS, LC/MS, and ICPMS analysis. This position also requires maintaining knowledge of the current US and International regulations/guidelines/policies applicable to West’s products and services. Serve as a Subject Matter expert by providing technical support regarding documentation and data integrity with the Laboratory. Mentor others and provide technical direction.

Essential Duties and Responsibilities

• Perform cGMP and technical Data Review on the analytical data generated in Lab Operations primarily for the Extractables group. This includes review primarily on GC/MS, LC/MS, and ICP/MS techniques.
• Perform review as needed in other areas of data review. This may include raw materials and finished goods, product performance, container closure integrity, leachables/extractables, particle analysis, stability, and/or microscopy/investigation.
• Be an expert on interpretation on various techniques available in the laboratory specifically mass spectrometry but also including but not limited to chromatography, CCI testing,USP/EP/JP/YBB Compendia Testing, ISO Testing, Instron and Zwick,  ICP, ICPMS, DSC, TGA, IR, UV,AA.
• Review the analytical raw data generated by first and second shift laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance.
• Review Electronic Data and Audit Trails for Data Integrity compliance.
• Support new GMP compliance guidance and data integrity initiatives.
• Collaborate with Laboratory Services, Project Management and Integrated Solutions.
• Maintain working knowledge of computer software packages including MS Office suite, Adobe, Master Control, LIMS, Empower and LMS.
• Collaborate with analysts on proposed path forward regarding documentation questions.
• Review Internal and External Client Reports generated from Lab Operations from multiple analysts utilizing multiple techniques for cGMP compliance and Data Integrity.
• Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance.
• Manage projects from Protocol to final report.
• Willingness to work with Project Management and Lab Operations in lab study designs and preparation of study protocols and meeting expected time lines involving constant prioritization and staying informed of changes that come along.
• Authoring of Work Instructions, where appropriate.
• Review and assist in the preparation of Work Instructions, Preformatted Notebooks, and Forms for Lab Operations.
• Train Data Reviewers and Supervisors and Analysts on Analytical data review and data integrity, as appropriate
• Keep current with new GMP compliance guidance and internal QA procedures.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Willingness to learn new and review new analytical techniques.
• Mentor others and provide technical direction.
• Provide leadership for cGMP compliance and technical training. Serve as a role model for positive leadership.
• Meet individual and departmental goals as required
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Education

• Bachelor's Degree in Chemistry or related field, or equivalent experience

Work Experience

• Minimum 5 years previous experience in data review, mass spectrometry
• Experience in FDA regulated environment, GMP compliance

Preferred Knowledge, Skills and Abilities

• Minimum 5 years of cGMP experience and knowledge, preferred
• Strong oral and written communication skills and attention to detail required.

• Preferred working knowledge of laboratory testing including methodologies
• Preferred knowledge of Compendia requirements a plus
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods' The employee must be able to maintain concentration and visual acuity on tasks for extended periods.
• The employee must perform visual inspection of product, color standards, raw materials, and graphics. Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification. Required to work 40 hours a week and some overtime.