Subject: Re: Aseptic Experience
From: TJ Bourdeau <[email-masked]>
To: Joyce Barreto <[email-masked]>
Date: Wed, 4 Feb 2026 12:43:33 -0500

Joyce,

Just checking in if there are any updates to my application or if there is any other information you need from me?

Thanks,

TJ

On Jan 29, 2026, at 12:10 PM, Joyce Barreto <[email-masked]> wrote:

Thank you for that information Timothy, I will be forwarding this to our operations manager and let you know if they request anything else or if we can move forward with the secondary screening/interview.

Cordially,

Joyce Barreto

Escalate Life Sciences

Administrative Assistant/Recruiter

Cell: (407) 987-7529

Office: (877) 213-7740

www.escalatesciences.com

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On Thu, Jan 29, 2026 at 1:30 AM TJ Bourdeau <[email-masked]> wrote:

Joyce,

Below is my response to your text sent on 01/28/26:

At Formulated Solutions, I’ve supported GMP manufacturing operations for approximately 3+ years, with direct involvement in quality oversight of controlled environment and aseptic-adjacent manufacturing, including nasal spray production lines.

My experience includes on-floor Quality support of manufacturing operations conducted in controlled environments where we required the dawning and doffing of “bunny suit” gowning, where I provided IPQA and FPQA oversight during active production runs. While I was not an aseptic operator, I was responsible for ensuring aseptic technique, procedural adherence, and documentation accuracy were maintained throughout manufacturing activities. This included line clearance verification, batch record review, real-time documentation support, and escalation of quality concerns during production.

As I progressed into Quality Supervisor and then QA Manager roles, my responsibilities expanded to include review and approval of batch records associated with aseptic/controlled-environment steps, deviation investigations related to aseptic practices or documentation errors, and CAPA implementation to strengthen right-first-time execution. I also supported inspection readiness and participated in FDA and customer audit shadowing, including on-floor support and follow-up documentation.

Overall, my aseptic manufacturing experience is rooted in quality governance and oversight of nasal spray manufacturing performed under GMP-controlled environments, with a strong focus on compliance, documentation integrity, and risk-based decision-making during live production.

Let me know if you need anything else from me,

TJ