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Quality Analyst 1

Your Role:

As a Quality Analyst 1, you will support the comprehensive quality activities, including entering, tracking and trending Environmental Monitoring (EM) data, managing timelines while ensuring the production environment is in a state of readiness. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed

 

As a Quality Analyst, you will support the daily operations of the Microbiology/EM and Manufacturing processes and fills. You will need to complete documentation, data entry, and data review for EM data in a timely manner.

Ensure that all required documentation including records and log books, is complete and entered in the timely manner and accurate according to the current GMP rules.

  • Complete training for initiating investigation.
  • Support SOP revision processes and other related documentation as needed.
  • Support the protocol and final report preparation for special studies and projects as needed.
  • Prioritize tasks to ensure that projects are completed by the assigned deadlines.
  • Support team building by participating in interviewing new talent.
  • Comply with company EH&S requirements. Promote a safety-first culture.

 

Physical Attributes:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties, the employee is:

  • Constantly required to sit and reach to use computers and other office/lab equipment
  • Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
  • Occasionally required to lift up to fifty (50) pounds
  • Constantly required to view objects at close and distant ranges
  • Frequently required to communicate with others

Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. The employee may be required to conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.

 

Who You Are:

 

Basic Qualifications:

  • Bachelor’s degree in Life Science disciple OR High School Diploma or GED AND 1 year of experience with Quality Control, CMO environment, Lean Manufacturing or Continuous Improvement

 

Preferred Qualifications:

  • Previous experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, automation, troubleshooting for machineries, equipment, software and data integrity is a plus.
  • Good understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals is a plus.
  • Knowledge of Aseptic Technique and Gowning is a plus

 

RSRMS

Job Requisition ID:  204953
Location:  Carlsbad
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Microbiology, QC, Testing, Data Entry, Science, Quality, Technology, Administrative

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