Every job has standards. But when it comes to pharmaceutical companies and those whose jobs are under intense scrutiny from the FDA on every project they work on, “standards” takes on an entirely diﬀerent meaning. One of Yoh’s clients needed help sourcing a number of positions for Validation assignments and insourced laboratory analysts. Complicating matters, the client’s staﬃng needs could change at a moment’s notice, requiring Yoh to always have new Validation experts at the ready.
Clients rarely bring new vendors onto a project when things are going great with the previous one. Not only was Yoh charged with ﬁlling positions, but the team signiﬁcantly overhauled the type of individual the client had been getting in the past and introduced an entirely new business model to assure quality and business goals were maintained and exceeded. Additionally, Yoh introduced a recruitment model that provided quick response to personnel needs and a new ﬁnancial model that signiﬁcantly reduced costs.
Initially a 2-3-member Validation team, Yoh eventually grew to support more than 85 Validation and insourced positions as well as supplying additional resources as client needs grew. Because of Yoh’s expert fulﬁllment team and process systems, the team was able to interview and hire new resources more than four times faster than before. Yoh accelerated overall hiring time and reduced time-to-interview.
• Commissioning & Qualiﬁcation Facilities, Utilities, Equipment
• Laboratory Instrument Qualiﬁcation R&D Laboratories QA/QC Laboratories
• Full System Life Cycle Document Development VMP Protocol Development and Execution SOP, URS Development
• Sample Preparation & Control
• QA documentation and Review
• Data Auditing
• Lead Scientists/Program Management
• Technical/Medical Writing
• Standards Assessments, including Gap Assessments
• Auditing (cGMP, Supplier, Internal, Process)
• Investigation and Root Cause Analysis Program Implementations
• Quality Risk Management Program Deployment
Surely, most people understand that the FDA assesses the foods people eat and the drugs they take and assume it probably has stringent guidelines to ensure all of it is safe. But few people truly comprehend the immense amount of scrutiny the FDA places on companies in the pharmaceutical space. From development, to testing and eventually public release, the amount of oversight required by the FDA demands near perfection from companies and from the folks assigned to assess their processes—Validation professionals.
Of course, it requires a team of experts with deep relationships in the industry to be able to source individuals for these important Validation projects. After all, when deadlines, entire projects, jobs and potentially millions of dollars are on the line, not having an expert who can assess process lifecycle when needed can put all of that in jeopardy.
For more than a quarter century, Yoh has been providing clients with talent for permanent and project positions in the Validation, Quality and Compliance space. And when one such client needed help sourcing a number of Validation pros while also introducing an entirely new model to assure quality and business goals were met, they called on the only staﬃng company in the industry who could handle such an important project.
Bringing Quality Growth
Initially, Yoh began our work with the pharmaceutical client as one staﬃng vendor working on a small, three-person Validation project within a single department of the company. And with 15 company departments that have little connection between them, working on a small project in a small corner
of the business can make it diﬃcult to stand out among the other vendors. Well, unless time and energy are invested into providing more than just quality talent, but also into identifying cost savings and process improvements each step of the way. Do this long enough, and eventually the cream does rise to the top.
As time went on, Yoh continued to grow our Validation presence before being asked to provide resources for a new project within the company’s laboratory organization
and Research & Development department. And once again, because of Yoh’s ability to surpass the client’s expectations for quality, cost and schedule, they asked the Yoh team to expand our reach again, providing resources for a 12-analyst insourced project within the client’s R&D lab. As is the case with most everything in business, time was of the essence. The process from identiﬁcation of candidates to full onboarding was streamlined from the typical 6-8 weeks to just 3-4 weeks to meet the client’s immediate demand.
During this project, Yoh signiﬁcantly overhauled to the type of individual the client had been receiving and added more experience, more knowledge and more skill. Yoh introduced a new business model with strict service-level agreements to assure quality was maintained and business goals were met and exceeded. (They were.) Yoh installed our proprietary recruitment model that provided quick response to client personnel needs and a ﬁnancial model that delivered cost savings and a reproducible skill set that allowed for rapid scalability.
It may seem like a lot, but when we’ve been doing it for 25-plus years, it becomes second nature.
Since partnering with Yoh on this Validation work and later the insourced lab analyst project, the scope of Yoh’s relationship with the client has grown exponentially. What was once only a 2-person project has expanded to more than 85 individuals working on a variety of projects across the business. Now,
Yoh supports biostatistics, data auditing, ﬁnancial program management, technical writing, sample preparation and more. The reason for this expansion? Our performance.
The Yoh team ranked highest in the organization in terms of retest and other performance factors, with Yoh’s top 5 producers holding the top-5 lowest retest rates in the laboratories. Yoh interviews and hires new resources more than four times faster than other in-house options because of our highly networked recruiting experts and proven process systems. Yoh implemented a board-review-like interview process where our experts invite 4-5 qualiﬁed candidates to interview with the Yoh management team, while the client team is present in a support role. This dramatically accelerated the hiring decision process by reducing interview time from 3-plus weeks to just one day.
But Yoh provides more than just solutions and results. Perhaps the team’s best quality is our ability to take problems, hiccups and annoyances oﬀ of the client’s plate and onto its own. Yoh provides resolutions to problems in just days when it would normally take the client months.
With Yoh’s state-of-the-art processes, tools and data, our teams are able to get clients the most complete workforce in the industry. If a process needs revamping, Yoh will do it. If a company needs a new candidate proﬁle, Yoh will introduce it. Our model is set up to bring not just experienced Validation and Quality candidates, but value to the client over the long haul. Our results validate our work.
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