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SQA Newsletter
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SQA News | Summer 2020
Gabe Silk
Wins & Challenges
In SQA’s 25 years, we’ve never seen the changes and challenges like those we’ve been through since the last newsletter. Like most businesses, we’ve had our share of struggles and wins, but to stay on the right side of the equation, we’ve had to pivot in several key areas along the way.
We adopted a motto I heard from an Australian business coach named Brad Sugars, “Survive and Thrive,” which wasn’t easy considering the sacrifices we all had to make to achieve the immediate impact required to right the ship. So, what has been the impact of COVID-19 on SQA? Immediate loss of almost half of the business due to plant closures, lock-downs, travel restrictions, etc. Even though we were immediately classified as an “Essential Business,” we still ran into an almost perfect storm of challenges.
We refocused resources, adapted our services, and jumped into an immediate cost cutting plan to minimize losses as we slowly grew our core business back to normal revenues. Most people took 25% salary cuts to achieve this while not laying anyone off. This is simply remarkable teamwork, and everyone did their part for us to ramp back toward “Thrive” status.
Thankfully, after hitting some important revenue goals, employees are now closer to their original earnings levels and soon will be where they were before the pandemic. We’ve learned so much during these tumultuous times about ways to be more efficient and to save money as an organization. I was close to signing a lease in February that would have committed us to 11 years and millions of dollars at a space that would not have worked for the headquarters team in a “post-COVID” world. We now are lease free and have found a new headquarters with more flexible terms and a suitable design.
Personally, my family has been through quite a bit. Both of my kids contracted COVID-19 at their respective college campuses, but fortunately, both are fine after symptoms subsided in a few days. The stress of me dealing with the age and circumstances of my parents has also been impactful to say the least, but thankfully they are fine and well and taking all necessary precautions to stay that way. Hopefully, when things get closer to normal, people will realize how lucky we are to be alive and that true happiness is easier to achieve after experiencing the struggles that arise along life’s daily journey.
Okay, enough pondering… Let’s get into our Wins and Challenges and get you all caught up with what’s happening! First, the Wins…
Wins
SQA Welcomes Dondi Pulse-Earle
We proudly added a superstar to the team last month. Please join me in welcoming Ms. Dondi Pulse-Earle to our technical team! As Principal of Life Science Products and Program, Dondi will lead our gene/cell therapy customers in the biologics world. She brings more than 25 years of experience in research, clinical trials, biologics licenses, quality assurance, quality control, and product distribution. In this new role, she will lead SQA within the Life Sciences market while supporting Field Engineering (FED)-type activities. Dondi’s career has included Manufacturing, Regulatory, and Quality senior leadership positions at the NIH, Duke University, Cord Blood Registry, ENCO Pharmaceutical Development, Inc., Alpha Nano LLC, and Creative Scientist, Inc. She is a regulatory and compliance Subject Matter Expert on GxP (GCP, GLP, GMP, GTP, and GVP), CMC, ICH, ISO, OSHA, USP, and WHO guidelines and regulations. She is located in the Raleigh, North Carolina area and will be traveling across the East Coast to support our company in many ways. Welcome, Dondi!
New Podcasts with Technical Guests
Recently, we received some great advice from a client I’ve known for quite a while to initiate an ambitious new podcast campaign. We interviewed several providers that specialize in professional podcasts within the supply chain arena, and we selected Sarah Barnes-Humphrey from letstalksupplychain.com. Sarah organized four episodes covering different subjects, and the results were shared with more than 40,000 followers. Our goal was to educate and entertain listeners with things we’ve seen in our 25-year history. Since the release, we’ve added many new Associates to the team, as well as new clients, so the program shows real promise. Please click on the links below if you want to take a listen, and a HUGE THANKS to the participants who joined me on the podcasts: Jeff Luckey, Martin VanTrieste, Jim McKay, and Ashley Goldberg!
SQA Mini Series Episode 1: Mission Control
SQA Mini Series Episode 2: Saving Lives
SQA Mini Series Episode 3: High Stakes
SQA Mini Series Episode 4: Beauty Secrets
Success with Remote Audits
For obvious reasons, we needed to quickly modify the way in which we conduct our audits around the world. Many clients still needed audits to be performed, but COVID-19 travel hurdles were simply too daunting to execute the audits, given the circumstances, and they still are. So what did we do? We rounded up our top auditors, had brainstorming sessions, and implemented a super-efficient way to accomplish most of what clients wanted, but in a remote capacity. From the enhanced logistics and legal requirements, to the security, communications, and even audio-visual aspects of remote audits, we took remote auditing to a new level. We even presented a webinar on the topic for the Parenteral Drug Association, so the entire industry could benefit from what we’d learned. While our audit numbers are rapidly returning to normal, it looks like remote auditing will have a permanent place in the supplier evaluation landscape. The number of remote audits we are performing has grown from almost zero in March to nearly 30% of our audit activity in August. Another key point worth mentioning is that a growing number of our pharmaceutical clients are having SQA conduct remote and on-site audits to expedite the development of a COVID-19 vaccine. It’s pretty cool when we play a critical role in making the world a safer place!
Challenges
Boy, we’ve had plenty, but let’s take an optimistic look at some important ones that come to mind these days.
Home Schooling / Training / Zoom Phenomena
I’ve got two kids in college as I type this, and it’s not the same when they’re attending classes via Zoom and getting a fraction of the education they should be getting. Half of what we learn happens outside of the classroom, such as in break-out sessions and noticing the non-verbal key elements of communication that aren’t fully present when you’re staring at your computer screen while your roommate could be playing video games. It’s true that there are a multitude of benefits with Zoom and other methods, but this whole experience is getting a little long in the tooth, and we are longing for the days when we will be able meet face to face and collaborate again. Travel costs and other expenses are way down, which is great, but there’s nothing like a meeting in person to obtain the most productive result.
Office Move
We’re super excited to find a new home in a beautiful building, but our team has had to deal with lots of distractions over the past few weeks. Although we’re on a voluntary program to come to HQ on a daily basis until January 2021, many employees are anxious to get back into the office to make things happen. We have four goals for getting this done as efficiently as possible: 1. Safety – This is paramount! We’ve chosen a furniture company called vari.com to purchase items that are specifically designed to reduce the spread of COVID-19 and facilitate proper social distancing. 2. Results – We feel that working together on site is key to achieving our ambitious revenue goals. 3. Teamwork – While each department has done a great job staying connected, we really miss the team energy that comes from a busy (but appropriately spaced) office! 4. Growth – New employees learn faster when they’re around other employees in the same environment. We need this type of environment to develop newer team members and give them the tools they need to succeed.
Election Uncertainty
I’m only 51 years old, but I’ve never seen the country in a place like this before. I can’t stand politics, but everywhere you look, someone has a passionate take in one direction or another, and many times for good reason. Our company has historically thrived under both parties’ administrations for different reasons, so I’m more of an interested bystander, but one thing is for certain, I can’t wait for the election to be over so we can keep cranking with less drama. While I fully support people standing up for whatever they believe in, things can get murky, with counter-productive interpretations in the workplace. Also, certain opportunities seem to be stuck in limbo until a result is reached in early November, and it simply can’t come fast enough so that we can plan accordingly. We love passion at SQA, but distractions are everywhere, and seemingly innocuous conversations can take a turn for the worse at a rapid pace. Uncertainty is a costly impediment, and I sure am happy that we will soon move forward.
Questions
We love some of the answers we’ve received in the past to some key questions; they’ve really helped shape our strategy. Please feel free to send answers/comments to these questions to me directly at mmckay@sqaservices.com.
How can SQA recruit more amazing professionals around the world with many companies downsizing?
Many times, huge opportunities appear during times like these – what are some things SQA can do to offer our clients more value, given the impact of COVID-19?
What can SQA do better? What are your true feelings about how we’ve done collectively over our 25-year history?
Thanks in advance for your thoughts!
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Lots to say this time around, but in closing, I’d like to share one quick thing that we did as a company during our last corporate-wide staff meeting on a Zoom call. I asked everyone to close their eyes for a quick minute and think hard about what it’s going to feel like to emerge out of this current environment filled with limited answers and seemingly endless challenges. I asked everyone to think hard about how it will feel to get their full salaries back so that they can pay their bills and live life as it was before March 2020. I also asked them to think about the world someday as a safer place with less hate and more harmony. And lastly, I asked them to think about how our company will continue to thrive and how important it is to count on one another as we sail these stormy seas.
We’ve got a ways to go, but some of these things are starting to happen, and we should all be thankful for the things we have in our lives and the beauty in this amazing world.
Yours in Quality,
Mike McKay
President/CEO
SQA Reaches a Quarter-Century
Out & About with Team SQA
SQA has been keeping everyone affected by COVID-19 in our thoughts, and we wish to thank all the healthcare providers working in hospitals and nursing homes across the world to help the elderly, chronically ill, rehabilitation patients, and now patients suffering from the new coronavirus strain. We appreciate your commitment to delivering #quality patient care.
In May, SpaceX became the first commercial operator to carry astronauts into space with the launch of the Falcon 9 rocket and Dragon crew capsule to the International Space Station (ISS), also marking the first time since 2011 that humans had been sent into orbit from US soil. New global players in the space industry like SpaceX have thrived thanks to new technologies and materials, as well as ambitious commercial partnerships. SQA’s long association with the industry continues with our managed inspection, audit, and engineering programs.
In June, SQA announced our new partnership with Rx-360 and its members. Today, we are pleased to share that we have some exciting work planned for later this month. Great planning leads to great results.
In July, SQA officially launched a new office in the Pacific Northwest. The office will be headed by Brendan Kreditor, NW Field Engineer Business Manager and Technical Business Manager. At SQA, our mission has always been to be a local extension of our clients, whenever and wherever they need us most. All of us here at headquarters in Los Angeles are thrilled to watch this endeavor take off!
Earlier this summer, SQA recorded a webinar on remote auditing, hosted with the Southern California chapter of PDA – Parenteral Drug Association. The webinar featured diverse perspectives from expert panelists and covered challenges, opportunities, and recommendations. Best of all, you can watch all 75 minutes for FREE!
We are very excited to share with you some recent additions to our website! While there is so much to explore, be sure you check out our updated Document Library. Just head over to the “About” tab on our website, and you’ll be able to find a library full of new materials, ranging from our SQA Brochure to our one-page rundowns on remote auditing and cybersecurity.
SQA appreciates every client partnership we have. One of our client partners at a leading personal care and consumer goods company recently informed us that they love working with SQA because of our ability to listen, shape, and dig deep into a #supplychain. We’re grateful for the compliment and truly believe that our inspection, audit, and remediation services are simply unrivaled. At SQA, we always strive to look closer and dig deeper.
SQA attended our first virtual conference is support of our long-term commitment to the PDA and FDA! Looking forward to seeing everyone in person next year!
In addition to our monthly regulatory and compliance blogs, SQA released a new awareness series to promote best practices in every supply chain. The latest blog post is about Process Failure Mode and Effects Analysis (PFMEA). Our Senior Engineering Director, Gilberto Jimenez, thinks the process is like solving a mystery.
Upcoming Events
While we are not able to attend many of our planned events this year to ensure health and safety for our teams, we are constantly updating our blog and website, as well as sending newsletters to keep in touch. Look out for more information on our remote audit practices and how we are able to stay connected as a community while we cannot physically be together.
Quality PERSONified
Meet Jason Anderson, SQA Field Engineering Director
Born and raised in South Texas, I grew up racing Motocross, Supercross, and hare scrambles, and I was a competitive swimmer in high school. I toured Russia in the summer of ’89 with People to People International for 23 days, and it was the most eye opening, humbling experience of my life. My professional career started off with summer jobs in both machine and composite shops, working on cars that go fast as well as custom interiors for airplanes. Since then, I accumulated 20+ years of experience in Operations, Manufacturing, and Quality. My last position prior to coming to work for SQA consisted of working with cross-functional teams to turn narrow- and wide-bodied aircraft into flying RVs (i.e., airplanes with bedrooms, state-of-the-art bathrooms, and conference rooms using cutting-edge technology, as well as exotic materials and finishes to achieve VVIP interiors). This position required working with VVIP customers to ensure that their expectations were met.
I joined SQA as an Associate in September 2014, working on an inspection remediation program inside a supplier site for a leading company in the semiconductor industry. I was blown away by the teamwork, Associate support system, and culture of SQA, and I am grateful that I was given this opportunity. It is hard to believe that six years have passed so quickly. The growth, partnership, and camaraderie I experience and am a part of each day are a testament to every individual at SQA.
My wife and I have four children (ages ranging from 23 to 16), including three boys and our youngest, a girl, who is currently a Varsity-level wrestler attending her junior year of high school. As a family, during our free time, we enjoy working on and restoring things that go fast, traveling, hiking, camping, and going on adventures. We also love to volunteer our time at local animal shelters and have large dogs of our own.
Associate Spotlight
Meet SQA Associate Wayne Lindsay
I was born and raised in New Mexico, and I earned my Bachelor of Science and Master of Materials Science degrees at Rice University in Houston, TX before eventually settling in Austin, TX, where I met and married Rachel, my wife of 25 years.
I have enjoyed a career spanning 35 years in Integrated Circuit (IC) Semiconductors with roles in Development, New Product Introduction, Supply Chain Management, Failure Analysis and Reliability, and Quality Assurance.
I joined SQA as an Associate Component Engineer in January 2017 as part of a multi-year SQA project supporting America’s premier private space companies’ efforts to certify their revolutionary launch vehicle and space capsule design for manned flights to the ISS (International Space Station).
I am now serving as a Supplier Quality Engineer on the LUCY mission, a government space probe to explore six Trojan asteroids, a unique family of asteroids that orbit the sun along with Jupiter, planned for an October 2021 launch. LUCY seeks to improve our knowledge of planetary origins and the formation of our solar system.
My time with SQA has proven to be both challenging and rewarding. I have been able to utilize my experience while contributing to the success of organizations working at the leading edge of space technology. It’s an exciting time to be engaged in the space exploration industry. I have especially enjoyed being able to achieve that elusive work-life balance that working from home affords. A happy telecommuter even before it became mandatory!
In 2016, Rachel and I moved to Albuquerque, NM, and it’s where we reside today. We enjoy entertaining, spending time outdoors, “parenting” a new puppy, and listening to music, especially live Americana music, which hopefully will be returning soon (we still have Austin in our blood!).
Hey Associates!
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