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Can BioPharma Quality Assurance Specialists Do It All?

Dec 27, 2012

When we imagine the biopharma industry as a whole, we tend to hover over the same key phrases: innovation, growth, discovery, etc. But in fact, with a few exceptions, the biopharma industry growth has gone sluggish in many states, and has grown in very few. 

Citing recent data from the U.S. Bureau of Labor and a well-designed report from the Massachusetts Biotechnology Council (MassBio), of the 15 “leading” biopharma manufacturing states, only five states have increased employment. As a whole, industry employment has declined by 7.9% since 2002Though these numbers are concerning, Massachusetts seems to be one extraordinary exception to the rule. By state, Massachusetts is twice as dense (as other states) in terms of biotechnology research, development and employment. Ironically, Massachusetts was the source of the recent Meningitis outbreak. 

But this hasn't been the only mistake/outbreak of 2012. We can do a news search for past events, but more importantly, where is the proof that lessons have been learned? How can we tell if the mistakes of 2012 will happen again? At a high level, looking at data from the last three years, we're headed in the right direction in terms of hiring. 

Diving deeper, is there evidence that biopharma and biotech companies are proactive? Is quality control and best practices in vaccine storage a pressing concern of theirs, and what have they done to address it? 

 

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The answer, in short statistical form, is yes. The institution of best practices and safety guidelines is a hot button issue for the biotechnology and biopharma industry. In fact, “Quality Assurance” and “Quality Control” job listings have been on a steady rise since 2008. Job listings from MassBio.org show over an 80% increase for these specialized positions since then. Other positions have increased by up to 30%, but in contrast to quality assurance and control; we can see clear-cut dedication. The employment spike shows a true and proactive HR response to the rising concerns of vaccine storage and handling

Still members of the biopharma industry must follow all best practice guidelines outlined by the CDC, and the push to hire “quality assurance specialists” is not a complete solution to the problem. Science fiction movies often illustrate the extreme horrors of vaccine mishandling and disease outbreaks that are caused by human error and/or relaxed security procedures. Despite the extremity of situational presentation in these films there really is an unspoken truth behind them. We cannot solely rely on capable employees. The rise in hiring for quality assurance and control positions is a promising sign, but there must be adequate technology to supplement the increase in manpower. Temperature monitoring is a good example, since employees must ensure that specific vaccines are stored at preset temperatures. However, truth is, no matter how many employees a company has, small changes in temperature must be monitored by certified and accurate technologies.  

What we can learn from these various statistics is that proactive deterrence (a theme we’ve been tossing around quite a bit in other industries), is a multi-faceted animal. While individual states may show evidence of “employment growth” and perhaps an uptick in manpower related to quality assurance; vaccines and medicine require more than just a brain and body.

Temperature monitors are ‘by-the-book’ devices that need to be used alongside competent employees. And in truth, all biotech and biopharma companies should have fault tolerant monitoring technology and quality assurance hardware. Institution of simple technologies such as buffer vials (for temperature sensors), will help decrease confusion and increase measurement accuracy for sensitive applications. The buffers provide a 'shield' around the sensor, preventing momentary temperature changes from an opened refrigerator door that can skew data or trigger false temperature alerts.

New employees will appreciate the availability of helpful (and simple) technology, which is important to establish safe handling practices that have become standardized and remain consistent within the various industries. Hopefully, the investment has gone both ways and this recent rise in specialized positions is piggy-backed by a push for 'battle-hardened' temperature monitoring systems. In preparation for 2013, we want to direct you towards a list of guidelines that must be followed as per the CDC for vaccine storage and handling. As the CDC shows, responsible quality assurance employees and reliable monitoring technology truly go hand-in-vial.

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