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QC Analyst

Novato, CA 94949

Posted: 10/29/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12418 Pay Rate: $25.00 - $28.00 Remote Friendly: Onsite

Job Description

=Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

PURPOSE:

The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by A280, Bradford, and UV Absorbance, Enzyme activity, HPLC/UPLC, and method validation.

CHARACTERISTICS:
  • Functional activities may include: performing a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorming further development or improvement ideas for procedures.
  • Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively.
  • Employee must be able to interpret results against defined criteria, begin to apply critical thinking to routine work. He/she should demonstrate an ability to evaluate results against trend reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active role in following up on atypical results or issues.
  • Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential. Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the work schedule flow permits, and maintain a positive attitude.

RESPONSIBILITIES:
  • Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
  • Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
  • Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
  • Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
  • Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  • Qualify as trainer for specified methods, provide training to less experienced staff.
  • Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
  • Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
  • Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
  • Perform other responsibilities as deemed necessary.

 

Job Requirements

QUALIFICATIONS
  • Bachelor of Science degree.
  • 0-3 years of relevant laboratory experience; QC specific experience is preferred.
  • Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
  • Demonstrated working knowledge with respect to certified functional activities.
  • Good documentation, written and verbal communication skills are essential.
  • Must possess the ability to perform most tasks with minimal supervision.
  • Computer literacy is required, with proficiency in Microsoft Word and Excel, and experience in Microsoft PowerPoint preferred.
  • Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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About Novato, CA

Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.