Data Review Specialist

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O.

West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

In this role, you will be responsible to independently provide review of analytical data for GMP compliance, accuracy, completeness, and adherence to applicable procedures and regulatory requirements. This role also requires a working knowledge of common analytical techniques and laboratory testing practices, including familiarity with laboratory data review and interpretation of analytical test results. In addition, mentor others and provide quality-minded direction as needed.

• Perform cGMP Data Review on the analytical data generated in WSS which may include raw materials and finished goods, product performance, container closure integrity, particle analysis, and/or microscopy/investigation.
• Review data from various analytical techniques in the laboratory including but not limited to CCI testing, USP/EP/JP/YBB Compendia Testing, ISO Testing, Instron and Zwick, ICP, 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 Quality.
• 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.
• Review and comment on Work Instructions, Preformatted Notebooks, and Forms for Lab Operations.
• 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 and review new analytical techniques.
• Meet individual and departmental goals as required.
• Conforms with and abides by all regulations, policies, work procedures, instructions, and safety rules.
• Exhibits regular, reliable, punctual, and predictable attendance.

• Bachelor's degree in Chemistry or a related scientific field, preferred.

• 3+ years of experience in data review, laboratory, and/or cGMP environment.

• Ability to work independently, multitask and thrive in fast-paced environment.
• Experience with managing Document Control activities within a regulated industry.
• Excellent written and verbal communication skills.
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
• Familiarity with Master Control, SAP/ERP system, and SharePoint.
• Must have effective problem-solving and interpersonal skills.

None:
No travel required

Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Effectively communicate and interface with various levels internally and with customers.

• Community Involvement:
  West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
• Continuous Learning & Development:
  Opportunities for…