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Quality Control Analyst I

Serán BioScience is looking to add an Analyst I to the Quality Control department. QC Analysts support the Quality Control laboratory's ongoing sample testing in support of Good Manufacturing Practices (GMP) and customer satisfaction for the production of novel pharmaceutical drug products. Adhering to strict standard operating procedures (SOP) and following good manufacturing practices (GMP) are required. Successful candidates will demonstrate strong attention to detail and focus within a fast-paced work environment with experience in teamwork, self-discipline, and proactive communication to ensure collective goals are achieved. GMP training available to successful candidates with a minimum of two years of good laboratory practices (GLP) experience.


Duties and Responsibilities
  • Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
  • Performs routine testing using analytical equipment including but not limited to HPLC, GC, KFC, Disso, etc. 
  • Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements
  • Drafts stability tables, sets-up stability studies, logs-in samples and standards
  • Cleans lab and glassware and disposes of analytical waste appropriately
  • Participates in process improvement and other non-routine projects
  • Conducts peer review of routine testing at the discretion of the relevant supervisor  
  • Performs hypothesis testing or investigative work for OOS results under management and SME guidance
  • Trains and mentors staff on established processes and procedures
  • Demonstrates cross-functional support capabilities with other QC teams 
  • Adheres to consistent and predictable in-person attendance
  • Responsibilities may increase in scope to align with company initiatives 
  • Performs other related duties as assigned


Required Skills and Abilities
  • Hands-on lab experience
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
  • Follows detailed written and oral instructions
  • Demonstrates ability to collaborate and work in cross-functional teams 
  • Strong organizational skills and attention to detail
  • Strong time management skills with a proven ability to meet deadlines
  • Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
  • Strong analytical and problem-solving skills
  • Accepts feedback from a variety of sources and constructively manages conflict  
  • Ability to prioritize tasks and to keep leadership apprised of performance to timelines
  • Proficient with Microsoft Office Suite or related software


Education and Experience
  • Bachelor’s degree in a scientific discipline or related field
  • 2 years of hands-on lab experience required
  • GMP experience not required but is preferred


Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Prolonged periods of sitting or standing while monitoring laboratory equipment 
  • Must be able to lift up to 15 pounds at times routinely, 30 pounds occasionally  
  • Motor skills for basic laboratory operations


Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.


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 and pet insurance.


The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

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What You Should Know About Quality Control Analyst I, Serán Bioscience

Serán BioScience is on the hunt for a talented Quality Control Analyst I to join our Quality Control department in the picturesque city of Bend, Oregon. This vital role is all about supporting our continuous sample testing efforts that ensure we meet Good Manufacturing Practices (GMP) and keep our customers happy with novel pharmaceutical products. By strictly adhering to our established Standard Operating Procedures (SOP) and maintaining GMP standards, you'll play an essential part in our operations. We're looking for someone who pays great attention to detail and thrives in a dynamic work environment, demonstrating skills in teamwork and proactive communication. As a Quality Control Analyst I, you will get hands-on experience in conducting routine tests with sophisticated analytical equipment like HPLC and GC, while also participating in innovative process improvement projects. If you possess at least two years of hands-on lab experience and are eager to learn, especially about GMP, we can't wait to meet you. The successful candidate will not only perform a range of laboratory tasks but will also collaborate across functions and help train our team members. So, if you're ready to take the next step in your career with us at Serán BioScience, we encourage you to apply today and find out more about the vibrant life in Bend, Oregon!

Frequently Asked Questions (FAQs) for Quality Control Analyst I Role at Serán Bioscience
What are the primary responsibilities of the Quality Control Analyst I at Serán BioScience?

As a Quality Control Analyst I at Serán BioScience, your primary responsibilities include adhering to Standard Operating Procedures (SOP), performing routine testing using various analytical equipment such as HPLC and GC, conducting stability studies, and participating in process improvement projects. You will also be involved in maintaining cleanliness in the laboratory and adhering to all safety protocols.

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What qualifications do I need to apply for the Quality Control Analyst I position at Serán BioScience?

To be considered for the Quality Control Analyst I position at Serán BioScience, you need a Bachelor's degree in a scientific discipline or a related field along with at least two years of hands-on laboratory experience. While GMP experience is preferred, it is not a strict requirement, as we provide training.

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What skills are important for a Quality Control Analyst I at Serán BioScience?

Key skills for a Quality Control Analyst I at Serán BioScience include strong analytical and problem-solving abilities, attention to detail, effective communication skills, and the ability to work collaboratively in cross-functional teams. Being organized and managing time well to meet deadlines in a fast-paced environment is crucial.

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How does Serán BioScience support the development of its Quality Control Analyst I staff?

Serán BioScience is committed to the professional growth of its staff, including the Quality Control Analyst I role. We provide GMP training for successful candidates and opportunities to participate in process improvement projects. You’ll also have the chance to mentor and train less experienced staff, enhancing your leadership skills.

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What are the work environments like for a Quality Control Analyst I at Serán BioScience?

The work environment for a Quality Control Analyst I at Serán BioScience is collaborative and fast-paced, emphasizing teamwork and precision. You'll work in a laboratory setting, where following good manufacturing practices and maintaining a clean, safe workspace is key to our success.

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Common Interview Questions for Quality Control Analyst I
How do you ensure compliance with Standard Operating Procedures in your previous lab experiences?

In my previous roles, I consistently reviewed and familiarized myself with Standard Operating Procedures to ensure adherence. I kept detailed notes and checklists to track compliance during experiments, thus minimizing chances for error.

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Can you describe your experience with analytical equipment?

I have hands-on experience with various analytical instruments such as HPLC and GC. I am comfortable performing routine calibrations and conducting troubleshooting to resolve any operational issues that may arise during testing.

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What steps do you take when faced with out-of-specification (OOS) results?

When faced with OOS results, I first verify the results by double-checking calculations and sample handling procedures. Then, I follow established protocols for investigation, collaborating with my supervisor and Subject Matter Experts to determine potential causes and corrective actions.

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How do you manage your time effectively in a fast-paced environment?

I prioritize tasks by breaking them down into smaller, manageable parts and setting clear deadlines. Additionally, I regularly communicate with my teammates to keep them updated on my progress and adapt my priorities based on evolving project needs.

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What approach do you take to maintain strong communication within a team?

I believe in fostering open communication by actively listening to team members and sharing my thoughts transparently. I seek feedback regularly and encourage team discussions to address any challenges we face collaboratively.

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How do you handle constructive criticism?

I view constructive criticism as an opportunity for growth. I take time to process feedback and reflect on how I can improve my skills or approach and am always eager to learn from others’ perspectives.

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What experience do you have with process improvement in the lab?

In my previous role, I participated in projects aimed at streamlining sample testing processes. I collected data on existing workflows, identified bottlenecks, and proposed solutions that improved efficiency and accuracy.

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Discuss a time you faced a challenging problem in the lab and how you resolved it.

I once encountered a significant discrepancy in test results. After careful investigation and collaboration with my colleagues, we discovered minor errors in sample preparation. We revised our procedures and implemented additional checks to prevent future errors.

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What motivates you to work in Quality Control?

I am passionate about ensuring product safety and efficacy, especially in pharmaceuticals. The satisfaction of contributing to high-quality outcomes that positively affect patients drives my dedication to Quality Control.

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Why do you want to join Serán BioScience as a Quality Control Analyst I?

I admire Serán BioScience's commitment to innovation and excellence in pharmaceuticals. I believe my skills align well with the company's goals, and I look forward to contributing to a team that values quality and teamwork.

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At Serán, we utilize a science-first methodology and cutting-edge technologies to enable our healthcare customers to discover and develop innovative medicines that improve patient health.

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EMPLOYMENT TYPE
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DATE POSTED
December 11, 2024

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