Find Careers in Engineering, Finance, IT, Science & More with Kelly Services | Job Description

Quality Control (QC) Stability Coordinator - San Diego, CA

Quality Control (QC) Stability Coordinator - San Diego, CA

Overall Responsibility:
This position is expected to oversee and execute stability programs including coordination of internal and external testing for company's San Diego projects. Independently defines and executes stability protocol  requirements for San Diego stability testing services. Independently collects, analyzes for trends and generates reports of stability data for San Diego clients.  This position exhibits project coordination skills, the ability to organize and schedule workload to satisfy regulatory and project deadlines as it relates to stability testing, and the ability to effectively convey project status communications to appropriate internal and external customers.

Essential Duties and Responsibilities:

  • Ensure that the activities of the stability program are in compliance with effective Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
  • Work closely with Program Managers, Clients, and QC analysts to ensure the timely execution of stability protocols, staging, time point pulls, in-house or external testing, and summary reports.
  • Write, revise, and review SOPs and GMP documentation as needed, such as stability study protocols, amendments, and summary reports.
  • Ensure that stability samples for all projects are properly placed on stability on time at the correct storage conditions and accurate logs are filled out for traceability.
  • Follow the requirements of each stability protocol to maintain all required timelines, including
  • ensuring that stability samples are pulled accurately at each time point, tested, and reported to Clients within the designated time frames.
  • Coordinate and oversee stability testing, both internal and external.
  • Review testing results and COAs for technical accuracy and compliance.
  • Ensure stability chambers are maintained in a calibrated / qualified state and meet ICH guidelines.
  • Attend planned meetings as needed to prioritize the stability program.
  • Recognize potential trends and alert the QC Director about potential issues.
  • Interface with auditors during internal, customer and regulatory inspections/audits.
  • Report excursions/out of specifications results and conduct investigations as needed.
  • Assure the implementation of appropriate and timely corrective actions.

General Duties and Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with company's policies and procedures.
  • Adheres to quality standards set by regulations and company policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of company's business.
  • Travels as needed to attend professional conferences, and train on new technologies.

Job Requirements:

  • Bachelor's degree (BS) in a relevant discipline (e.g., Chemistry, Biological Sciences, Bioengineering, etc.).
  • Minimum five (5) years experience working in a GMP laboratory/manufacturing environment.
  • Working knowledge of analytical instrumentation and methodologies such as HPLC, wet chemistry, and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is a plus.
  • Comprehensive and extensive knowledge in the full range of quality control testing and assessment in the pharmaceutical industry.
  • Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
  • Excellent attention to detail.
  • Ability to work well under pressure, multi-task and prioritize work assignments with little supervision.
  • Excellent written and oral communication skills.

For immediate consideration, apply today!  Questions?  Call/Email Airika at 562-206-2707 or

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

Related jobs you might be interested in...
In Vivo Research Associate...
San Diego CA
7 days ago
Full Time
Project/Program Manager - ...
San Diego CA
13 days ago
Full Time
Account Manager (CRO) - Sa...
San Diego CA
17 days ago
Full Time
One moment please...

Create an Account or sign in using one of your social networks by clicking an icon below. You can also Create an Account by uploading your resume

As of Sep 19, 2019 our security requirements for account passwords have been updated and you are required to click the Forgot Password link to create a new password.
Forgot Password        
Verify Email
First Name
Last Name
Verify Password


Choose your resume:
You currently don't have any resumes uploaded. Please upload one to continue.
Resume Title
Upload a Resume
Candidate Experience Site Guest User
Time Zone:
EST (Eastern Standard)
Area(s) of expertise:
Communication Preference:
Thank you for your interest in this job.
Your resume has been successfully submitted.

What would you like to do next?

One moment please...