Data Review Specialist

This position is hybrid in Exton, PA. Candidates applying to this role must be located within a 50 mile radius 

Who We Are:

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?  

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

As the Data Review Specialist, you will be responsible to independently provide analytical of data generated for all internal and external customers of the Laboratory Operations group in Exton.  This position also requires maintaining knowledge of the current US and International regulations/guidelines/policies applicable to West's products and services.  Mentor others and provide technical direction.

Essential Duties and Responsibilities:

• Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, leachables/extractables, particle analysis, stability, and/or microscopy/investigation.
• Review various techniques available in the laboratory including but not limited to CCI testing, chromatography including mass spectrometry, 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.
• 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 new and review new analytical techniques.
• 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.

Basic Qualifications:

• Education or Equivalent Experience: Bachelor's in Chemistry or related field, preferred
• Experience: 3-5 years of experience

Preferred Knowledge, Skills and Abilities:

• Minimum 3 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

Travel Requirements:

• Must be able to travel up to 5% of the time.

Physical & Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents.
• Work under deadlines with constant interruptions

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.