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Quality Assurance Specialist

Connexion Systems + Engineering

Vista, CA

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JOB DETAILS
SALARY
$35–$37 Per Hour
LOCATION
Vista, CA
POSTED
30+ days ago
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Quality Assurance Specialist – Investigations 
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type
  • Duration: 7+ month contract
  • Pay rate: $35-$37/hr
  • Job Location: Vista, CA
  • Schedule: M-F, 8am – 4:30pm
  • Job#: bh18757

Description:
We are seeking a Manufacturing Assurance Specialist to support quality operations within a GMP cleanroom manufacturing environment. This role focuses on investigations, deviation management, and quality systems support within a regulated biopharmaceutical manufacturing setting.

The ideal candidate will have hands-on experience in manufacturing, validation, or aseptic processing and a strong background in investigations, CAPA, and documentation within a GMP environment.
Key Responsibilities
  • Investigate manufacturing deviations, environmental monitoring excursions, calibration events, and related quality issues.
  • Determine root cause, assignable cause, and product/production impact during investigations.
  • Prepare detailed written investigation reports and documentation supporting corrective and preventive actions.
  • Collaborate closely with Manufacturing, Quality Operations, Quality Control, Facilities, and Quality Assurance teams to resolve quality issues.
  • Conduct facility and utility inspections, reporting any findings that may impact production.
  • Support CAPA generation, execution, and implementation.
  • Assist with document change management (DCM), plant change control, and related quality system activities.
  • Review manufacturing records, environmental monitoring documentation, and facility documentation as part of investigation activities.
  • Maintain current knowledge of regulatory requirements and industry standards.
  • Work independently while maintaining strong collaboration with cross-functional teams.
Required Qualifications
  • Direct hands-on experience in manufacturing, validation, and/or aseptic processing within a regulated environment.
  • Experience working in a cleanroom manufacturing environment.
  • Strong technical writing skills with experience preparing investigation reports or quality documentation.
  • Demonstrated ability to perform root cause analysis and structured problem-solving.
  • Strong organizational, analytical, and decision-making skills.
  • Ability to interact effectively with cross-functional teams at all organizational levels.
  • Proficiency with Microsoft Office (Word, Excel, Outlook) and familiarity with systems such as SAP, LIMS, or document control/change management systems.
Additional Requirements
  • Ability to work in a sanitized cleanroom environment and fully gown as required.
  • Must be able to lift or push up to 40 lbs when necessary.
  • Ability to manage multiple priorities and meet targeted deadlines.
  • Flexibility to support a 24/7 manufacturing operation if needed.
This is an excellent opportunity for a quality professional with GMP manufacturing experience to contribute to investigation and quality improvement efforts in a regulated production environment.


Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you shortly.

You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.

If you are active in a job search but this job is not for you, please reach out to 

jobpostings@csetalent.com

. We would be glad to help you find the perfect job!

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/

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