---
title: 'Quality Assurance Senior Specialist at Serán BioScience'
canonical: 'https://feeny.ai/job/quality-assurance-senior-specialist-seran-bioscience-bend-5g686q6yww63'
type: 'job'
last_seen: '2026-09-11'
---

# Quality Assurance Senior Specialist at Serán BioScience

- **Company:** Serán BioScience
- **Location:** Bend, OR
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-09-01
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/seranbio/e5fe7bcb-7139-48ce-9e29-9b18a248dcd2

## Job description

Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products.  Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program.  Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement.  Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.

Duties & Responsibilities

- Performs internal and third-party audits.
- Supports regulatory inspections and client audits.  Manages and improves audit program.
- Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.
- Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
- Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
- Administers the quality risk management program and conducts risk assessments
- Document authorship, review, and approval of SOPs, reports, and quality records.

Required Skills & Abilities

- Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
- Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
- Excellent verbal and written communication skills
- Excellent time management skills with a proven ability to meet deadlines
- Excellent organizational skills and attention to detail
- Demonstrated ability to collaborate and work in cross-functional teams
- Scientific curiosity and willingness to learn
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate

Education & Experience

- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
- Working knowledge of Veeva preferred

Physical Requirements

- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at [63047 Layton Ave, Bend, OR 97701](https://www.bing.com/ck/a?!&&p=89945e36682bf05113ab303fd3f1c9a15c6f7e74683fcc8c429813f125b36844JmltdHM9MTczMzI3MDQwMA&ptn=3&ver=2&hsh=4&fclid=076ddb4a-efd8-6d3a-2ff2-cfdaee446c2a&u=a1L21hcHM_Jm1lcGk9MTI3fn5Vbmtub3dufkFkZHJlc3NfTGluayZ0eT0xOCZxPVNlciVDMyVBMW4lMjBCaW9zY2llbmNlJTJDJTIwTExDJnNzPXlwaWQuWU44NzN4MTUzMDIzMTAwNDQ1OTA4OTg5NTkmcHBvaXM9NDQuMDg5NzE0MDUwMjkyOTdfLTEyMS4yOTE2NDEyMzUzNTE1Nl9TZXIlQzMlQTFuJTIwQmlvc2NpZW5jZSUyQyUyMExMQ19ZTjg3M3gxNTMwMjMxMDA0NDU5MDg5ODk1OX4mY3A9NDQuMDg5NzE0fi0xMjEuMjkxNjQxJnY9MiZzVj0xJkZPUk09TVBTUlBM&ntb=1)

## About Serán BioScience

## Company Overview
- **One-liner**: Serán BioScience is a science-driven drug development partner providing integrated formulation, particle engineering, and clinical manufacturing services to pharmaceutical and biotechnology companies.
- **Entity Type**: Private (Privately Held)
- **Headquarters**: Bend, Oregon, United States
- **Founded**: 2016
- **Founders**: Dr. Smithey (President, CEO, and Co-founder)

## Core Business
- **Primary Industry**: Biotechnology / Drug Development (Contract Development and Manufacturing Organization – CDMO)
- **Target Customers**: B2B – Pharmaceutical and biotechnology companies (from preclinical to commercial stage)
- **Mission**: To provide optimized drug development and manufacturing services for clients, from discovery to the clinic, using a science-first approach to accelerate medicines to patients.

## Products & Services
- **Preformulation Services**: Physicochemical characterization and early feasibility studies to guide formulation strategy.
- **Formulation Development**: Design of robust formulations for poorly soluble compounds using spray drying, hot melt extrusion, fluid bed processing, granulation, and solid dosage forms (tablets, capsules, multiparticulates).
- **Particle Engineering**: Custom-built spray dryers capable of producing nano-to-micro particles; expertise in spray-dried dispersions and engineered particles for inhalation.
- **Clinical Manufacturing**: cGMP manufacturing of clinical trial materials (suspensions, capsules, tablets) with on-site ICH stability storage.
- **Commercial Manufacturing**: A 100,000 sq ft commercial manufacturing campus under construction, including large-scale spray drying for late-stage clinical and commercial supply.
- **Quality Control Laboratory**: Full release, stability, and microbial testing capabilities.

## Market Standing
- **Valuation/Market Cap**: Not publicly available
- **Key Metric**: Total Funding – Not disclosed; Headcount of 146 employees (+0.6% YoY as of latest LinkedIn data)
- **Notable Investors/Partners**: Not publicly disclosed
- **Growth Signals**: Constructing a 100,000 sq ft commercial manufacturing facility; expanding team to over 200 members; adding new development facilities and quality control labs; LinkedIn follower growth of +29.1% year-over-year.

## Competitive Advantages
- **Science-First Approach**: Employs predictive design tools, novel chemistry, and advanced analytical methods from the earliest stages to de-risk development.
- **Particle Engineering Leadership**: Decades of experience with poorly soluble compounds; proprietary spray drying and particle engineering technologies (nano-structures to micro-particulates).
- **End-to-End Support**: Integrated services from preformulation through commercial manufacturing, reducing handoffs and timelines.
- **Right From the Start™ Methodology**: Parallel development of drug product intermediates and final dosage forms to accelerate programs.

## Strategic Focus
- **Commercial Scale-Up**: Investing in a dedicated commercial manufacturing campus to support clients’ late-stage and marketed products.
- **Technology Expansion**: Continuously expanding technical capabilities (spray drying, hot melt extrusion, fluid bed processing) and facility footprint.
- **Talent Acquisition**: Growing the team of scientists, engineers, and support staff to serve an increasing pipeline of complex drug molecules.

## Why Work Here
- **Culture**: Collaborative, respectful, and fun environment where every role contributes to delivering novel therapies. Emphasis on mentoring and continuous learning.
- **Work-Life Balance**: Central Oregon lifestyle with outdoor recreation access; standard business hours (with alternative shifts in manufacturing/QC/QA).
- **On-Site Requirement**: All employees are expected to work on the Bend campus; remote flexibility considered on a case-by-case basis.
- **Benefits**: Paid time off, employer retirement contributions (no match or vesting required after 90 days), fully funded medical/dental/vision for employee and household, basic life and long-term disability, Employee Assistance Program.
- **Ideal Applicant**: Scientific background with GLP/GMP knowledge; inquisitive problem-solver who follows SOPs and collaborates toward common goals.

## Sources
1. [seranbio.com](https://www.seranbio.com/about)
2. [linkedin.com](https://linkedin.com/company/seran-bioscience)
3. [seranbio.com](https://www.seranbio.com/careers)
4. [seranbio.com](https://www.seranbio.com/?portfolioCats=34%2C23%2C29%2C35%2C22%2C24%2C30%2C25%2C28%2C31)
5. [jobs.lever.co](https://jobs.lever.co/seranbio)

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