Scientist, P&P

RXinsider LTD.; Exton (PA); Hybrid; USD 70,000 - 95,000; Full time

Job summary

West Pharmaceutical Services in Exton, PA is seeking a Laboratory Data Analyst to support data review and ensure compliance with cGMP and Data Integrity. The role requires daily SAP review, audit trails, and collaboration with analysts to prepare technical reports.

Minimum 3 years in a laboratory, experience in pharmaceutical/medical device fields, and ability to work in a hybrid onsite setting (3 days/week) are essential.

Qualifications

• BS in biomedical engineering or related technical degree.
• Minimum 3 years of professional lab experience.
• Experience in pharmaceutical/medical device field.

Responsibilities

• Perform data review to ensure cGMP compliance and DI.
• Execute daily SAP review and lock results with audit trails.
• Develop and validate methods and prepare technical reports.
• Train analysts and interact with internal/external clients.
• Maintain safety procedures and stay current with new analytical techniques.

Skills

Data review

cGMP awareness

Data Integrity

Team collaboration

Education

BS in biomedical engineering

Related technical degree

Tools

SAP

Lab instrumentation

Audit trails

Job description

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

No Relocation is privded for this oppportunity

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

In this role you will support the laboratory with data review generated to comply with cGMP and Data Integrity (DI). You will be responsible to ensure raw data and electronic data are reviewed on a timely manner and comply with cGMP, DI and West requirements. You will execute daily SAP review and locking of results along with audit trail reviews.

Essential Duties And Responsibilities

• Perform analysis using various techniques including established and experimental test methods.
• Use instrumentation both qualitatively and quantitatively where appropriate.
  • Intron/Zwick/UV/or 3D Printing & CAD experience is a plus
• Manage projects from protocol to final report.
• Train and certify analysts as appropriate.
• Develop and validate methods.
• Keep current with new analytical technology.
• Possess ability to work independently and as part of a team with self‑motivation, adaptability, and a positive attitude.
• Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques.
• Prepare work instructions, SOPs, and qualification documentation.
• Prepare lab study designs and prepare study plans and protocols.
• Interact with internal and external clients as needed.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigations, OOS, and OOT as required.
• Serve as a role model for positive leadership.
• Meet individual and departmental goals as required.
• Apply required cGMP regulations and internal QA procedures
• Adhere to established laboratory safety procedures.
• Other responsibilities as assigned including but limit to performing clean room testing.

Education

• BS in biomedical engineering, chemical engineering, mechanical engineering, or related technical degre

Work Experience

• Minimum 3 years 3 -5 years of professional experience in a lab environment required and
• Experience in pharmaceutical/medical device field and implementing laboratory training programs required and

Preferred Knowledge, Skills And Abilities

• cGMP
• ISO and USP/EP compendia
• Strong oral and written communication skills and attention to detail required
• 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

None: No travel required

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• Job-related activities that require a physical activity such as standing in laboratory environment
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

Shift

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.