People are the Chemistry - Jennifer Roark
Bringing 21 years of experience with Eurofins Lancaster Laboratories to her new role as Manager of Chemistry & Container Testing for Eurofins Medical Device Testing, Jen Roark sees great potential for this new business venture. Previously, Jen was Manager of Extractables & Leachables, overseeing relevant container closure, combination products and single-use systems testing, which translates well for enhancing many existing client partnerships as well as opening doors to new relationships with an expanded portfolio of medical device service offerings. Here’s a slice of Jen’s life:
What does your current job entail?
As Manager, I am building our capabilities for plastics and glass container testing as well as elastomeric closures per the various compendia (USP, EP, JP). I am also adding new services such as force testing and leak testing of drug-product packaging, combination-product packaging, and sterile-barrier packaging for medical devices. New leak testing techniques include vacuum decay, pressure decay, high-voltage leak detection (HVLD), helium mass spectrometry (helium leak), and FMS Oxygen Headspace Analysis. I serve as the technical contact for client inquiries, and I entertain client visits, audits, and meetings via teleconference. I also manage the financial aspects of the business to ensure that the group is successful.
What is the scope of your group?
My group performs the physiochemical testing required for drug product containers, combination products, and medical devices. We also perform Container Closure Integrity testing using various methods such as dye ingress, dye penetration, as well as the leak-testing techniques detailed above. Syringeability tests and other forms of force testing for syringes are also performed in my group. These tests include break-free force, glide force, and activation force for the needle safety guard using an Instron Model 3343 single-column table frame. We also support the chemical characterization and ethylene oxide residuals tests associated with ISO 10993.
What process improvements does your group initiate to serve clients better?
As we are always looking for ways to streamline processes and workflows, we have set up the department using many of the best practices implemented by the Raw Materials Testing groups. One process we have recently implemented that should produce significant efficiency gains is the use of electronic notebooks for documentation. These notebooks will help to reduce documentation errors such as omissions of critical steps or observable data. When the documentation is complete, the need for rework due to a documentation error is greatly reduced.
Why should clients trust us with their projects?
Quality has always been and always will be our top priority. We value all of the feedback that we have obtained from clients over the years through audits and comments on data packages and reports or CoAs. We incorporate that feedback and implement these recommendations where we can to continuously improve our data, which is our product. We also hire the best talent and ensure career development for our analysts. It is our expectation that analysts maintain their knowledge base in their particular areas of expertise, and always keep abreast of the newest technologies applicable to the types of testing offered in our groups. We also strive to provide our customers with excellent service every time they award us their work. We can be depended upon to deliver high-quality results when the client needs them.
You’ve been here for 21 years and seen countless changes. Is there anything that hasn’t changed during your tenure?
The thing that hasn’t changed in the past 21 years is the same thing that has kept me here that long, and makes me want to stay her until I retire (or until they kick me out, whichever comes first!). It’s our people. The company culture has always fostered building teamwork, which in turn, allows us to build strong relationships with our coworkers and even our clients. I often think of my coworkers as my extended family, and I am so very proud to be a member of such a great team for such a long time!
What kind of volunteer activities have you been involved with?
I am currently volunteering on the ASTM E55.04 Subcommittee for the development of a consensus standard for determining extractables from components associated with single use systems for bioprocessing. Prior to managing the Chemistry and Container Testing group, I supervised the Extractables and Leachables Testing group for 10 years. I am considered a subject matter expert in extractables and leachables testing, and therefore have been very actively participating in the drafting of ASTM WK43975 Standard Practice for Determining and Characterizing BioProcess Extractables from Components, Sub-assemblies and Assemblies used in Single-use Applications.
And when you’re not working?
My other job is Mom and spouse! Together with my wonderful husband, we are raising two amazing children who love baseball, soccer, swim team, skiing, and of course, the beach. My favorite thing to do is ski, and I cannot wait until winter is here. When it’s not winter, I enjoy sailing a boat that one of my former coworkers gave me.