Lab Associate

West Pharmaceutical Services•Kinston, NC

3d•Onsite

About The Position

This is an onsite position requiring the team member to be onsite 5 days a 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? 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 SummaryIn this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.Essential Duties and ResponsibilitiesPerform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.With guidance, assist in completing projects from protocol to final report.Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.Train new analysts as appropriate.Exercises creativity in developing new test / debugging methods.Keep current with new analytical techniques and technology.Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.Support laboratory management in data quality-documentation, and archiving.Maintain compliance to cGMP and ISO requirements and established safety procedures.May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.May handle Test Requests – write, review, and approve, and maintain traceability of samples.

Requirements

Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
High School Diploma required
Experience working in a laboratory or cGMP/pharmaceutical environment preferred
Laboratory administrative/Coordinator/Analyst role preferred
Must be able to stand for long periods of time
Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
Read and interpret data, information and documents
Must maintain the ability to work well with others in a variety of situations
Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
Ability to make independent and sound judgments
Observe and interpret situations, analyze and solve problems

Nice To Haves

Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
Method development and validation
Willingness to learn and apply new analytical techniques
Proficient in Microsoft Office tools and capable to learn other software programs
Able to review regulatory code and learn safety standards
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Able to comply with the company’s safety and quality policies at all times

Responsibilities

Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures.
Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
With guidance, assist in completing projects from protocol to final report.
Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
Train new analysts as appropriate.
Exercises creativity in developing new test / debugging methods.
Keep current with new analytical techniques and technology.
Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
Support laboratory management in data quality-documentation, and archiving.
Maintain compliance to cGMP and ISO requirements and established safety procedures.
May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents.
Proficiently use MS Office products for data gathering, reporting, and data entry.
May handle Test Requests – write, review, and approve, and maintain traceability of samples.